Methods for Treating Neurological Disorders Using Nutrient Compositions

ABSTRACT

Nutrient compositions comprising botanical extracts and methods of their use for treating, inter alia, autism or apraxia and/or ameliorating one or more symptoms thereof are disclosed. The use of such compositions for enhancing cognitive function and/or one or more aspects thereof, or for treating stroke or seizures and/or ameliorating one or more symptoms thereof are also disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a continuation application of U.S. application Ser.No. 17/714,236, filed Apr. 6, 2022, presently allowed, which is acontinuation application of U.S. Pat. No. 11,369,652, issued Jun. 28,2022 which is a continuation application of U.S. Pat. No. 10,722,546,issued Jul. 28, 2020, which is a continuation application of U.S. Pat.No. 9,931,365, issued Apr. 3, 2018 which is a continuation applicationof U.S. Pat. No. 8,962,042, issued Feb. 24, 2015, which is a nationalstage application of PCT/US2011/053700 filed Sep. 28, 2011, claims thebenefit of U.S. Provisional Application No. 61/387,227 filed Sep. 28,2010 and U.S. Provisional Application No. 61/473,258 filed Apr. 8, 2011,the disclosures of which are hereby incorporated herein by reference intheir entireties.

FIELD OF THE INVENTION

The present invention relates to methods for treating, inter alia,autism or apraxia and/or ameliorating one or more symptoms thereof.

BACKGROUND OF THE INVENTION

Autism is a complex developmental disorder that interferes with, amongother things, the normal development of the brain in the areas of socialinteraction, imagination, reasoning ability, cognition, andcommunication skills. It typically appears during the first three yearsof life and is the result of a neurological disorder which affects thefunctioning of the brain. Typically, autistic children and adults havedifficulties in verbal and non-verbal communication, socialinteractions, and leisure or play activities. Formerly a rare disorder,autism has increased in the last decade by 300% to 500% in the UnitedStates and many other countries. Clearly, a means of prevention and/ortreatment of what is now an epidemic are needed.

According to the Autism Society of America (hereinafter the “ASA”),autism is generally characterized as one of five disorders coming underthe umbrella of Pervasive Developmental Disorders (PDD), a category ofneurological disorders characterized by severe and pervasive impairmentin several areas of development, including social interaction andcommunications skills (DSM-IV-TR). The five disorders under PDD areAutistic Disorder, Asperger's Disorder, Childhood DisintegrativeDisorder (CDD), Rett's Disorder, and PDD-Not Otherwise Specified(PDD-NOS). Specific diagnostic criteria for each of these disorders canbe found in the Diagnostic & Statistical Manual of Mental Disorders(DSM-IV-TR) as distributed by the American Psychiatric Association(APA).

The most common of the Pervasive Developmental Disorders, autismspectrum disorders affect an estimated 1 in approximately 110 births onaverage according to a 2009 study by the Center for Disease Control.Indeed, as of 2003-2004, as many as 1.5 million Americans are believedto have some form of autism. Such a number is on the rise inasmuch as,based on statistics from the U.S. Department of Education and othergovernmental agencies, autism is growing at a rate of 10-17 percent peryear. At these rates, the ASA estimates that the prevalence of autismcould easily reach 4 million Americans in the next decade.

The overall incidence of autism is, for the most part, globallyconsistent. Indeed, autism knows no racial, ethnic, or socialboundaries, and family income, lifestyle, and educational levels do notaffect the chance of autism's occurrence. However, it has been found tobe four times more prevalent in boys than girls.

Although autism is defined by a certain set of behaviors, it is aspectrum disorder in that its symptoms and characteristics can bepresent in a wide variety of combinations, from mild to severe.Therefore, autistic children and adults can exhibit any combination ofthe behaviors in any degree of severity. Two individuals, both with thesame diagnosis, may have varying skills and display very differentactions.

Indeed, every person with autism is an individual, and like allindividuals, each has a unique personality and combination ofcharacteristics. Those only mildly affected may exhibit slight delays inlanguage or communication and may face greater challenges in socialinteractions. For example, one may have difficulty initiating and/ormaintaining a conversation. Communication by autistic children or adultsis often displayed as talking at others (for example, a monologue on afavorite subject that continues despite attempts by others to interjectcomments).

Autism requires those affected by it to process and respond toinformation in unique ways. At times, aggressive and/or self-injuriousbehavior may exist. The following traits, as identified by the ASA, mayalso be present in persons with autism: Insistence on sameness orresistance to change; Difficulty in expressing needs; (i.e. usesgestures or pointing instead of words); Repeating words or phrases inplace of normal, responsive language; laughing, crying, showing distressfor reasons not apparent to others; prefers to be alone or aloof manner;tantrums; difficulty in mixing with others; may not want to cuddle or becuddled; little or no eye contact; unresponsive to normal teachingmethods; sustained odd play; spins objects; inappropriate attachments toobjects; apparent over-sensitivity or under-sensitivity to pain; no realfears of danger; noticeable physical over-activity or extremeunder-activity; uneven gross/fine motor skills; and/or not responsive toverbal cues (i.e. acts as if deaf although hearing tests in normalrange).

For most people, our senses help us to understand what we areexperiencing. For example, our senses of touch, smell, sound, and tastecollaborate to give us a full experience of eating a ripe apple: thefeel of the smooth skin as we pick it up, its sweet smell as we move itto our mouth, the crunch of the fruit being bitten into, and the juicesrunning down our face as we enjoy the bite. For individuals with autism,however, sensory integration problems are common. In particular, theirsenses may be either over- or under-active. The fuzz of a kiwi mayactually be experienced as painful; a sweet, fruity smell may cause agagging reflex. Some children or adults with autism are particularlysensitive to sound, so that even the most ordinary daily noises arepainful. Many professionals feel that some of the typical autismbehaviors are actually a result of sensory integration difficulties.

While there is no known single known cause for autism, it is generallyaccepted that it is caused by abnormalities in brain structure orfunction. The shape and structure of the brain in autistic versusnon-autistic children show differences when brain scans are viewed.Currently the link between heredity, genetics and medical problems arebeing investigated by researchers, as well as a number of othertheories. The theory of a genetic basis of the disorder is supported bythe fact that, in many families, there appears to be a pattern of autismor related disabilities. While no one gene has been identified ascausing autism, researchers are searching for irregular segments ofgenetic code that autistic children may have inherited. Whileresearchers have not yet identified a single “trigger” that causesautism to develop, it also appears that some children are born with asusceptibility to autism.

Other researchers are investigating the possibility that under certainconditions, a cluster of unstable genes may interfere with braindevelopment resulting in autism. Still other researchers areinvestigating problems during pregnancy or delivery as well asenvironmental factors such as viral infections, metabolic imbalances,and exposure to environmental chemicals.

According to the ASA, autism tends to occur more frequently thanexpected among individuals who have certain medical conditions,including Fragile X syndrome, tuberous sclerosis, congenital rubellasyndrome, and untreated phenylketonuria (PKU). Some harmful substancesingested during pregnancy also have been associated with an increasedrisk of autism. Early in 2002, The Agency for Toxic Substances andDisease Registry (ATSDR) prepared a literature review of hazardouschemical exposures and autism found no compelling evidence for anassociation; however, there was very limited research and more needs tobe done.

Notwithstanding the foregoing, and to the best of Applicant's knowledge,there is no cure for autism. There are, however, a number ofmedications, developed for other conditions, which have been found to besomewhat helpful in treating a limited number of the symptoms andbehaviors frequently found in individuals with autism, such ashyperactivity, impulsivity, attention difficulties, and anxiety.Examples of medications used to treat symptoms associated with autisminclude: Serotonin re-uptake inhibitors (e.g. clomipramine (Anafranil),fluvoxamine (Luvox) and fluoxetine (Prozac)) which have been effectivein treating depression, obsessive-compulsive behaviors, and anxiety thatare sometimes present in autism. Studies have shown that they may reducethe frequency and intensity of repetitive behaviors, and may decreaseirritability, tantrums and aggressive behavior. Some children have shownimprovements in eye contact and responsiveness. Other drugs, such asElavil, Wellbutrin, Valium, Ativan and Xanax, require more studies to bedone but may have a role in reducing behavioral symptoms.

Over the past 35 years, the most widely studied psychopharmacologicagents in autism have been anti-psychotic medications. Originallydeveloped for treating schizophrenia, these drugs have been found todecrease hyperactivity, stereotypic behaviors, withdrawal and aggressionin autistic children. Four that have been approved by the FDA areclozapine (Clozaril), risperidone (Risperdal), olanzapine (Zyprexa) andquetiapine (Seroquel). However, only risperidone has been investigatedin a controlled study of adults with autism. Unfortunately, like theantidepressants, these drugs all have adverse side effects, including,but not limited to, sedation.

Stimulants, such as Ritalin, Adderall, and Dexedrine, used to treathyperactivity in children with ADHD have also been prescribed forchildren with autism. Although few studies have been done, they mayincrease focus, and decrease impulsivity and hyperactivity in autism,particularly in higher-functioning children. Unfortunately, adversebehavioral side effects are often observed.

While many of the above-identified medications do appear to be somewhathelpful in treating a limited number of the symptoms and behaviorsfrequently found in individuals with autism, a wide variety of sideeffects are associated with such medications.

Apraxia is another of the neurological disorders or conditions thateffects brain function. It is typically defined as the inability tocarry out useful or skilled acts while motor power and mental capacityremain intact. Apraxia is generally understood to usually be caused bydamage to specific areas of the cerebrum. Apraxia may be further dividedinto kinetic, or motor, apraxia, ideational apraxia, and constructionalapraxia. Kinetic apraxia affects the upper extremities so that theindividual cannot carry out fine motor acts, such as turning a key in alock, even though there is no muscle weakness. Ideational apraxia ischaracterized by the inability to formulate a plan of action and isusually caused by a lesion of the cerebral cortex. This may manifestitself as a plan is never fully organized, with the part that isorganized not remembered long enough to be performed. Alternatively,portions of an act may be completed in an improper sequence. Forexample, an individual may strike a match to light a campfire but thenhold the match until it burns his fingers. Ideokinetic apraxia may becaused by an interruption of impulses in the association tracts of thenervous system, such that there is no coordination between ideation andmotor activity. An affected individual will complain, for example, thathe cannot use his hand, but then he will slap a mosquito with it. Peoplewith ideokinetic apraxia are unable to perform certain acts (e.g.,whistling or making a fist) upon command but are able to do soautomatically. Ideokinetic apraxia is usually caused by a lesion in thesupramarginal gyms of the cerebral cortex. Constructional apraxia,typically caused by a lesion in the right cerebral hemisphere, is theinability to construct elements in the correct fashion to form ameaningful whole—e.g., being unable to build a structure with blocks orto copy a design.

Various disorders and diseases exist that affect cognitive function.Cognitive function may be generally described as including at leastthree different components: attention, learning, and memory. Each ofthese components and their respective levels affect the overall level ofa subject's cognitive ability. For instance, while Alzheimer's Diseasepatients suffer from a loss of overall cognition and thus deteriorationof each of these characteristics, it is the loss of memory that is mostoften associated with the disease. In other diseases, patients sufferfrom cognitive dysfunction or impairment that is more predominatelyassociated with different characteristics of cognition. Other conditionsinclude general dementias associated with other neurological diseases,aging, and treatment of conditions that can cause deleterious effects onmental capacity, such as cancer treatments, stroke/ischemia, and mentalretardation.

Cognitive dysfunction creates a variety of problems for today's society.Therefore, scientists have made efforts to develop cognitive enhancersor cognition activators. The cognition enhancers or activators that havebeen developed are generally classified to include nootropics,vasodilators, metabolic enhancers, psychostimulants, cholinergic agents,biogenic amine drugs, and neuropeptides.

U.S. Pat. No. 6,399,114 discloses certain compositions for treatingnervous system disorders including autism, ADD, ADHD, hyperactivitydisorder and depression.

U.S. Pat. No. 7,456,224 discloses methods for treating autism comprisingthe step of administering an effective amount of a medicamentcharacterized as a NMDA-receptor antagonist or a pharmaceuticallyacceptable salt thereof.

U.S. Pat. No. 7,335,651 discloses methods for promoting healthy bodyweight and improving a number of related physiological factors.

U.S. Pat. No. 7,232,575 discloses certain nutrient supplementscomprising minerals, vitamins, amino acids, and agents capable ofdelivering cysteine in vivo and methods of treating autism involvingadministration of the nutrient supplements.

U.S. Pat. No. 7,632,532 discloses certain delivery systems fornutraceuticals using a low caloric chocolate base for containing one ormore nutraceuticals.

Gymnema sylvestre (Retz.) R. Br. ex Schult (belonging to the familyAsclepiadaceae) is a woody climbing plant that grows in the tropicalforests of central and southern India. The leaves are used in herbalmedicine preparations. It is an Ayurvedic herb, and used to be known as“destroyer of sugar”, because in ancient times Ayurvedic physiciansobserved that chewing a few leaves of Gymnema sylvestre suppressed thetaste of sugar. Today it is used all over India for controlling bloodsugar (Baskaran K., Kizar Ahamath B., Radha Shanmugasundaram K.,Shanmugasundaram E. R., Antidiabetic effect of a leaf extract fromGymnema sylvestre in non-insulin-dependent diabetes mellitus patients, JEthnopharmacol, volume 30, pages 295 to 300, 1990).

Gymnema sylvestre is stomachic, diuretic, refrigerant, astringent, andtonic. It has been found to increase urine output and reducehyperglycemia in both animal and human studies.

U.S. Pat. No. 6,379,673 discloses an herbal formulation for therapeuticand cosmetic applications for the treatment of general skin disordersthat contains an aqueous extract of Gymnena sylvestre.

U.S. Pat. No. 7,632,532 discloses certain systems and methods for oraladministration of various nutraceuticals such as plant concentrates,particularly in confectionary or chocolate matrices utilizing a novelsweetening composition.

JP-A 2001 226 274 discloses a lipase inhibitor that comprises a crudedrug or its extract such as guava leaf (Psidium guajava), hop (Humuluslupulus), Apocynum venetum leaf, Gymnema leaf (Gymnema sylvestre),and/or Gardenia fructus (Gardenia jasminoides var. grandiflora). Thelipase inhibitor according to JP-A 2001 226 274 has the followingfunctions: anorectic, antidiabetic, antilipemic and hypotensive.

WO 01/17486 discloses a method for the cosmetic treatment of skinimpairments and baldness by applying deanol or derivatives thereof(deanol is also known as dimethylaminoethanol).

JP-A 2292208 discloses a cosmetic preparation that contains substancesobtained from leaves of Gymnema sylvestre, Zizyphus jujuba, bark andpeelings of Malus pumila and further substances.

JP-A 02292208 discloses a cosmetic preparation that contains substancesobtained from leaves of Gymnema sylvestre. The substances are obtainedby extraction. The solvent used for extraction is water, alcohol, ormixtures of water and alcohol. The cosmetic preparation according toJP-A 02292208 can be used for the treatment of blotches and freckles.

JP-A 01258623 discloses a composition that stimulates hair growth andblood circulation and prevents baldness. It contains chitin and chitosanin combination with hydrolysing enzymes, organic acids, and substancesof Gymnema sylvestre and Isagol (hemicellulose of Plantag).

It has now been surprisingly discovered that administering an effectiveamount of certain nutrient compositions appears to substantially improvefrontal executive functions associated with apraxia, autism, traumaticbrain injury, global delays, and/or ADHD, including, but not limited to,speech expression and decreased perseveration. Furthermore,administering such nutrient compositions has not been shown to causeside effects associated with medications previously used to treat thesymptoms of apraxia, autism, traumatic brain injury, global delays, andADHD. The present invention is directed to these, as well as otherimportant ends.

SUMMARY OF THE INVENTION

Accordingly, the present invention is directed, in part, to methods fortreating apraxia, autism, speech impairments, traumatic brain injury,seizure disorders, epilepsy, global delays, or ADHD, or methods forameliorating one or more of the symptoms thereof.

In certain embodiments, the present invention provides methods fortreating apraxia, autism, speech impairments, traumatic brain injury,seizure disorders, epilepsy, global delays, or ADHD, comprisingadministering to a patient in need thereof a nutrient composition thatameliorates one or more symptoms of apraxia, autism, speech impairments,traumatic brain injury, seizure disorders, epilepsy, global delays, orADHD, said nutrient composition comprising an effective amount of amixture or purified mixture thereof comprising three or more botanicalextracts selected from the group of botanicals consisting of Gymnemasylvestre, Commiphora mukul, Curcuma longa, Camellia sinensis, Emblicaofficinalis, and Terminalis chebula.

The present invention is also directed in part to methods for treatingapraxia, autism, speech impairments, traumatic brain injury, seizuredisorders, epilepsy, global delays, or ADHD, comprising administering toa patient in need thereof a nutrient composition that ameliorates one ormore symptoms of apraxia, autism, speech impairments, traumatic braininjury, seizure disorders, epilepsy, global delays, or ADHD, saidnutrient composition comprising an effective amount of a mixture orpurified mixture thereof comprising three or more botanical extractsselected from the group of botanicals consisting of Gymnema sylvestre,Commiphora mukul, Curcuma longa, Camellia sinensis, Emblica officinalis,and Terminalis chebula; and

an effective amount of an omega 3 fatty acid or pharmaceuticallyacceptable or food grade acceptable derivative thereof.

In certain other embodiments, the present invention provides nutrientcompositions useful for treating apraxia, autism, speech impairments,traumatic brain injury, seizure disorders, epilepsy, global delays, orADHD, comprising administering to a patient in need thereof a nutrientcomposition that ameliorates one or more symptoms of apraxia, autism,speech impairments, traumatic brain injury, seizure disorders, epilepsy,global delays, or ADHD, said nutrient composition comprising:

an effective amount of a mixture or purified mixture thereof comprisingthree or more botanical extracts selected from the group of botanicalsconsisting of Gymnema sylvestre, Commiphora mukul, Curcuma longa,Camellia sinensis, Emblica officinalis, and Terminalis chebula; and

an effective amount of an omega 3 fatty acid or pharmaceuticallyacceptable or food grade acceptable derivative thereof.

In one aspect, the invention is directed to methods for enhancingcognitive function, comprising the step of:

administering to a patient in need thereof a nutrient compositioncomprising an effective amount of a mixture or purified mixture thereofcomprising three or more botanical extracts selected from the group ofbotanicals consisting of Gymnema sylvestre, Commiphora mukul, Curcumalonga, Camellia sinensis, Emblica officinalis, and Terminalis chebula.

In one aspect, the invention is directed to methods for enhancingcognitive function, comprising the step of:

administering to a patient in need thereof a nutrient compositioncomprising an effective amount of a mixture or purified mixture thereofcomprising three or more botanical extracts selected from the group ofbotanicals consisting of Gymnema sylvestre, Commiphora mukul, Curcumalonga, Camellia sinensis, Emblica officinalis, and Terminalis chebula;and

an effective amount of an omega 3 fatty acid or pharmaceuticallyacceptable or food grade acceptable derivative thereof.

In one aspect, the invention is directed to methods for treating stroke,comprising the step of:

administering to a patient in need thereof a nutrient compositioncomprising an effective amount of a mixture or purified mixture thereofcomprising three or more botanical extracts selected from the group ofbotanicals consisting of Gymnema sylvestre, Commiphora mukul, Curcumalonga, Camellia sinensis, Emblica officinalis, and Terminalis chebula.

In one aspect, the invention is directed to methods for treating stroke,comprising the step of:

administering to a patient in need thereof a nutrient compositioncomprising an effective amount of a mixture or purified mixture thereofcomprising three or more botanical extracts selected from the group ofbotanicals consisting of Gymnema sylvestre, Commiphora mukul, Curcumalonga, Camellia sinensis, Emblica officinalis, and Terminalis chebula;and

an effective amount of an omega 3 fatty acid or pharmaceuticallyacceptable or food grade acceptable derivative thereof.

DETAILED DESCRIPTION OF ILLUSTRATIVE EMBODIMENTS

As employed above and throughout the disclosure, the following terms,unless otherwise indicated, shall be understood to have the followingmeanings.

The term “autism” as used herein includes those disorders (i.e.,classical autism and autism spectrum), and pervasive developmentaldisorder (PDD) (i.e., with autistic tendencies) as identified by thecriteria set forth in the American Psychiatric Association's Diagnosticand Statistic Manual (DSM IV, or a later version of DSM). PervasiveDevelopmental Disorders (as described in DSM IV) are characterized bysevere and pervasive impairment in several areas of development:reciprocal social interaction skills, communication skills, or thepresence of stereotyped behavior, interests, and activities. Thequalitative impairments that define these conditions are distinctlydeviant relative to the individual's developmental level or mental age.Pervasive Developmental Disorders include Autistic Disorder, Rett'sDisorder, Childhood Disintegrative Disorder, Asperger's Disorder, andPervasive Developmental Disorder Not Otherwise Specified. Thesedisorders are usually evident in the first years of life and are oftenassociated with some degree of mental retardation. Furthermore, althoughterms like “psychosis” and “childhood schizophrenia” were once used torefer to individuals with these conditions, there is considerableevidence that the Pervasive Developmental Disorders are distinct fromschizophrenia.

The essential features of Autistic Disorder (described in DSM IV,Section 299.00) are the presence of markedly abnormal or impaireddevelopment in social interaction and communication and a markedlyrestricted repertoire of activity and interests. Manifestations of thedisorder vary greatly depending on the developmental level andchronological age of the individual. Autistic Disorder is sometimesreferred to as early infantile autism, childhood autism, or Kanner'sautism. Early epidemiological studies suggested rates of AutisticDisorder of 2-5 cases per 10,000 individuals (with a greater frequencyin males), but much higher rates have been reported recently. Bydefinition, the onset of Autistic Disorder is prior to age 3 years.

The essential feature of Rett's Disorder (described in DSM IV, Section299.80) is the development of multiple specific deficits following aperiod of normal functioning after birth. Rett's Disorder is typicallyassociated with Severe or Profound Mental Retardation, and has beendiagnosed only in females.

The essential feature of Childhood Disintegrative Disorder (described inDSM IV, Section 299.10) is a marked regression in multiple areas offunctioning following a period of at least 2 years of apparently normaldevelopment. Childhood Disintegrative Disorder is usually associatedwith Severe Mental Retardation, and has also been termed Heller'ssyndrome, dementia infantilis, or disintegrative psychosis.

The essential features of Asperger's Disorder (described in DSM IV,Section 299.80) are severe and sustained impairment in socialinteraction and the development of restricted, repetitive patterns ofbehavior, interests, and activities. The disturbance must causeclinically significant impairment in social, occupational, or otherimportant areas of functioning. In contrast to Autistic Disorder, thereare no clinically significant delays in language (e.g., single words areused by those that are 2 years of age, communicative phrases are used bythose that are 3 years of age). In addition, there are no clinicallysignificant delays in cognitive development or in the development ofage-appropriate self-help skills, adaptive behavior (other than insocial interaction), and curiosity about the environment in childhood.

The category Pervasive Developmental Disorder Not Otherwise Specified(including Atypical Autism) (described in DSM IV, Section 299.80) isapplied when there is a severe and pervasive impairment in thedevelopment of reciprocal social interaction or verbal and nonverbalcommunication skills, or when stereotyped behavior, interests, andactivities are present, but the criteria are not met for a specificPervasive Developmental Disorder, Schizophrenia, Schizotypal PersonalityDisorder, or Avoidant Personality Disorder.

Autism is generally understood as a group of related disorders, wherepeople diagnosed with the condition experience its symptoms to a greateror lesser extent. At the severe end of the spectrum is low-functioningautism, which can cause extensive impairments in all areas ofdevelopment. Usually, low functioning (or severely) autistic childrenhave little or no language, some degree of mental challenges, littleawareness of other people and expectations. Autistic symptoms such asgestures, rituals and many other odd behaviors are visibly apparent inlower functioning children. Self injurious behavior is much more commonin low-functioning autistics than in their high-functioning peers.Individuals who are labeled as having a severe autism with cognitiveimpairment are individuals who have greater difficulty with socialskills, and academic performance. They often have few readily knownand/or socially appropriate means for communicating with others.Children with severe autism may also engage in more sensory-relatedactivities such as hand flapping, spinning, or rocking. People withsevere autism usually do not speak, often do not understand receptivelanguage, do not care nor do they wish to engage in conversation unlessit is absolutely necessary and it is extremely limited due to the lackof speech, do not respond well to behavioral therapy, and do not show agreat deal of improvement. For children with low functioning autismbeing mentally challenge is common, epilepsy is common, and otherdisorders may be present as well. They do not express emotions (exceptanger) and whether they experience those emotions is unknown due totheir inability to communicate. Some of the more common traits of thosewith severe autism include hand-wringing, appearance of poorlycoordinated manner of walking/stepping, severely impaired expressive andreceptive language development, lack of or infrequent initiation, lackof usual nonverbal gestures (i.e., pointing, head shake, nod), inabilityto control improper behavior, avoidance of eye contact or use of eyecontact in odd ways, a preference to be alone, an iInability to imitate(body movement, vocal, motor), a propensity to engage in rhythmic bodymovements such as rocking, pacing, hand flapping, toe walking, spinning,either over- and under-sensitivity to sound, smell, touch, visualstimulus and pain, unusual displays of emotion such as giggling orweeping for no apparent reason, impulsivity, aggressive and/orself-injurious behavior.

As used herein, the term “stimming” refers to self-stimulatingbehaviors, i.e., stereotyped or repetitive movements or posturing of thebody. They include mannerisms of the hands (such as handflapping, fingertwisting or flicking, rubbing, or wringing hands), body (such asrocking, swaying, or pacing), and odd posturing (such as posturing ofthe fingers, hands, or arms). Stimming may involve objects such astossing string in the air or twisting pieces of lint. These mannerismsmay appear not to have any meaning or function, although they may havesignificance for the child, such as providing sensory stimulation (alsoreferred to as self-stimulating behavior), communicating to avoiddemands, or request a desired object or attention, or soothing when waryor anxious. These repetitive mannerisms are common in children withautism spectrum disorders.

The term “apraxia” as used herein is a neurological motor speechimpairment—a breakdown in the transmission of messages from the brain tothe muscles in the jaw, cheeks, lips, tongue, and palate. There is noobvious weakness in these muscles and the patient may well be able tohappily move them when not trying to speak. A patient with apraxia knowswhat he wants to say, but has an impairment in the signal from the brainto the mouth. Further detail on apraxia, autism, and/or relatedconditions such as oral apraxia, hypotonia, sensory integrationdysfunction and the like are disclosed in “The Late Talker-What to do ifyour child isn't Talking Yet” by Marilyn Agin MD, Lisa Geng, and MalcolmJ. Nicholl, St Martin's Press May 2003. As used herein. The terms “oralapraxia” and “verbal apraxia” are both neurologically based motorplanning impairments that inhibit an individual's ability to performtask on command. Verbal apraxia affects the individual's expressiveability on command. Classic symptoms noted for verbal apraxia includethe ability or lack thereof to say a word on command. This may befurther accentuated by the length and/or complexity of the utterance.

Oral apraxia affects an individual's ability facially communicate suchas to smile, make facial expressions, and the like (e.g., blow kisses orbubbles). Other symptoms may include “blank” looks in children whichaffect the way they are viewed by others. Individuals with oral apraxiaalso have an inability to lick food off their lips, and will typicallyuse their finger instead.

An individual may have verbal without oral apraxia. However, anindividual diagnosed with oral apraxia will likely later be diagnosedwith verbal apraxia as well. Today most that are diagnosed with oral andor verbal apraxia present mutlifaceted symptoms and also have sensoryintegration dysfunction, hypotonia (typically mild) and motor planningimpairments in the body, also referred to as global or limb apraxia, orcalled “dyspraxia” in the UK. In the US, the diagnosis term apraxia anddyspraxia are used interchangeably however.

“Side effect” refers to a consequence other than the one(s) for which anagent or measure is used, as the adverse effects produced by a drug,especially on a tissue or organ system other than the one sought to bebenefited by its administration.

“Effective amount” refers to an amount of a nutrient composition asdescribed herein that may be therapeutically effective to treat thesymptoms of particular disease, disorder, condition, or side effect.Such diseases, disorders, conditions, and side effects include, but arenot limited to, those pathological conditions associated with thetreatment of apraxia, autism, traumatic brain injury, global delays, orADHD. Thus, for example, the term “effective amount,” when used inconnection with nutrient compositions of the invention, for thetreatment of apraxia, autism, traumatic brain injury, global delays,ADHD, refers to the treatment of one or more of the symptoms related toapraxia, autism, traumatic brain injury, global delays, or ADHD, such asfor example lowered ability or capability with regard to speecharticulation, complexity and sophistication of sentence structure,written and spoken language comprehension and use, word, recall memoryand/or learning capabilities, fine and gross motor skills including alsomulti tasking, sense of humor, awareness of surroundings, use of facialexpressions especially as non-verbal cues, task focus, socialcommunication skills, and or seizure instances. The term “effectiveamount,” when used in connection with nutrient compositions of theinvention, for the treatment of stroke, refers to the treatment of oneor more of the symptoms related to the symptoms of stroke, such as forexample, hemiplegia and muscle weakness of the face, numbness, reductionin sensory or vibratory sensation, initial flaccidity (hypotonicity),replaced by spasticity (hypertonicity), hyperreflexia, and obligatorysynergies, if one of the three prominent central nervous systempathways—the spinothalamic tract, corticospinal tract, or dorsal column(medial lemniscus), is affected. A stroke affecting the brain stem andbrain therefore can produce symptoms relating to deficits in one or moreof the twelve cranial nerves, including such symptoms as altered smell,taste, hearing, or vision (total or partial), drooping of eyelid(ptosis) and weakness of ocular muscles, decreased reflexes: gag,swallow, pupil reactivity to light, decreased sensation and muscleweakness of the face, balance problems and nystagmus, altered breathingand heart rate, weakness in sternocleidomastoid muscle with inability toturn head to one side, and weakness in tongue (inability to protrudeand/or move from side to side). If the cerebral cortex is involved, theCNS pathways can again be affected, but also may produce one or more ofthe following symptoms: aphasia (difficulty with verbal expression,auditory comprehension, reading and/or writing Broca's or Wernicke'sarea typically involved), dysarthria (motor speech disorder resultingfrom neurological injury), apraxia (altered voluntary movements), visualfield defect, memory deficits (involvement of temporal lobe),hemineglect (involvement of parietal lobe), disorganized thinking,confusion, hypersexual gestures (with involvement of frontal lobe), andanosognosia (persistent denial of the existence of a, usuallystroke-related, deficit). If the cerebellum is involved, the patient mayhave one or more of the following symptoms: trouble walking, alteredmovement coordination, vertigo and/or disequilibrium. The term“effective amount,” when used in connection with nutrient compositionsof the invention, for the enhancement of cognitive function, refers tothe enhancement of one or more of the aspects of cognitive functions,such as for example, attention, learning, and memory, particularlymemory. The characteristics of cognitive function may also be viewed interms of their right and left brained aspects. For example, descriptionof left brain function may employ terms such as logical, sequential,rational, analytical, or objective thought, or those brain processesinvolving looking at parts of the whole that are being observed orstudied. Examples include concrete thought, focus and academicachievements. Description of right brain function characteristics, onthe other hand, may employ terms such as random/intuitive, holistic,synthesizing, subjective, or those brain processes involving looking atthe whole that is being observed or studied. Examples includeimagination or creativity. Enhancement in cognitive function may includesome or all of right brain or left brain characteristics, or some or allof both. The cognitive function enhancements relating to focus mayinclude aspects of improved attention to surroundings, or absorption ofdetails relating to the thing studied, or both. Improvement in cognitivefunction may also appear and/or be recognized by improvements in testedIQ of a patient.

“Stroke” refers to a condition due to the lack of oxygen to the brain.Strokes can be classified into two major categories: ischemic andhemorrhagic. Ischemic strokes are those that are caused by interruptionof the blood supply, while hemorrhagic strokes are the ones which resultfrom rupture of a blood vessel or an abnormal vascular structure. Braintissue ceases to function if deprived of oxygen for more than 60 to 90seconds and after approximately three hours, will suffer irreversibleinjury possibly leading to death of the tissue, i.e., infarction.Symptoms of the occurrence of a stroke depend on the area of the brainand/or CNS affected. In most cases, the symptoms affect only one side ofthe body (unilateral). Depending on the part of the brain affected, thedefect in the brain is usually on the opposite side of the body.However, since these pathways also travel in the spinal cord and anylesion there can also produce these symptoms, the presence of any one ofthese symptoms does not necessarily indicate a stroke.

“Dosage unit” refers to physically discrete units suited as unitarydosages for the particular individual to be treated. Each unit maycontain a predetermined quantity of active extract (s) calculated toproduce the desired therapeutic effect(s) in association with therequired pharmaceutical or edible food carrier. The specification forthe dosage unit forms of the invention may be dictated by (a) the uniquecharacteristics of the active ingredients in the nutrient compositionsand the particular therapeutic effect(s) to be achieved, and (b) thelimitations inherent in the art of compounding such nutrientcompositions. In certain preferred embodiments, each unit may contain apredetermined quantity of active extract(s), omega 3 fatty acid(s)and/or agent(s) for the treatment of apraxia, autism, speechimpairments, traumatic brain injury, seizure disorders, epilepsy, globaldelays, or ADHD or any mixture thereof calculated to produce the desiredtherapeutic effect(s) in association with an optional carrier. Thespecification for the dosage unit forms of the invention may be dictatedby (a) the unique characteristics of the active extract(s), omega 3fatty acid(s) and/or agent(s) for the treatment of apraxia, autism,speech impairments, traumatic brain injury, seizure disorders, epilepsy,global delays, or ADHD or any mixture thereof and the particulartherapeutic effect(s) to be achieved, and (b) the limitations inherentin the art of compounding such active extract(s), omega 3 fatty acid(s)and/or agent(s) for the treatment of apraxia, autism, speechimpairments, traumatic brain injury, seizure disorders, epilepsy, globaldelays, or ADHD or any mixture thereof.

“Patient” refers to animals, including mammals, preferably humans.

The terms “treat”, “treatment” or “treating”, as used herein, generallyrefer to palliative (e.g., therapeutic), preventative (e.g.,prophylactic), inhibitory and/or curative treatment. Preferably, theterms “treat”, “treatment” and/or “treating” refer to palliative,inhibitory, and/or curative treatment, with palliative and inhibitorytreatment being more preferred. In particularly preferred embodiments,the terms “treat”, “treatment” or “treating” refer to palliativetreatment.

“In combination with,” refers, in certain embodiments, to the concurrentadministration to a patient of a nutrient composition of the inventionincluding, for example, an effective amount of a mixture or purifiedmixture thereof comprising three or more botanical extracts selectedfrom the group of botanicals consisting of Gymnema sylvestre, Commiphoramukul, Curcuma longa, Camellia sinensis, Emblica officinalis, andTerminalis chebula; and one or more additional agents including, forexample, an omega 3 fatty acid, or an agent for the treatment of andmixtures thereof), preferably an effective amount of an omega 3 fattyacid or pharmaceutically acceptable or food grade acceptable derivativethereof. When administered in combination, each component may beadministered at the same time or sequentially in any order at differentpoints in time. Thus, each component may be administered separately butsufficiently closely in time so as to provide the desired therapeuticeffect.

Combinations of components and/or variables are permissible only if suchcombinations result in stable compositions.

The invention relates to nutrient compositions containing thesebotanical extracts and methods for their pharmaceutical use. In someembodiments, the compositions of the present invention may be useful,inter alia, in methods for treating apraxia, autism, traumatic braininjury, global delays, or ADHD or any of the symptoms thereof. In otherembodiments, the compositions of the present invention may be useful,inter alia, in methods for treating learning disabilities including, forexample, ADHD. In still other embodiments, the compositions of thepresent invention may be useful, inter alia, in methods for treatingneurologically based multifaceted communication and/or behavioralimpairments. In certain embodiments, the compositions of the presentinvention may be useful, inter alia, for treating stroke or any of thesymptoms associated with stroke. In yet other embodiments, thecompositions of the present invention may be useful, inter alia, forenhancing cognitive function, or in other embodiments, for treatingcognitive dysfunction.

Accordingly, in one embodiment, the invention provides methods fortreating a neurological condition comprising administering to a patientin need thereof a nutrient composition that ameliorates one or moresymptoms of the neurological condition, said nutrient compositioncomprising an effective amount of a mixture or purified mixture thereofcomprising three or more botanical extracts selected from the group ofbotanicals consisting of Gymnema sylvestre, Commiphora mukul, Curcumalonga, Camellia sinensis, Emblica officinalis, and Terminalis chebula,said neurological condition being selected from the group consisting ofautism, apraxia, speech impairments, ADHD, traumatic brain injury,seizure disorders, epilepsy, and global delays, preferably autism orapraxia, more preferably autism. In certain alternatively preferredembodiments, the neurological condition is a seizure disorder. In otheralternatively preferred embodiments, the neurological condition is aADHD.

In certain other embodiments, the invention provides nutrientcompositions comprising:

an effective amount of a mixture or purified mixture thereof comprisingthree or more botanical extracts selected from the group of botanicalsconsisting of Gymnema sylvestre, Commiphora mukul, Curcuma longa,Camellia sinensis, Emblica officinalis, and Terminalis chebula; and

an effective amount of an omega 3 fatty acid or pharmaceuticallyacceptable or food grade acceptable derivative thereof.

In accordance with certain preferred aspects of the invention, there areprovided methods of preventing inhibiting or treating apraxia, autism,speech impairments, traumatic brain injury, seizure disorders, epilepsy,global delays, or ADHD comprising the step of administering to saidpatient an effective amount of a nutrient composition of the inventionincluding, for example, a composition comprising:

an effective amount of a mixture or purified mixture thereof comprisingthree or more botanical extracts selected from the group of botanicalsconsisting of Gymnema sylvestre, Commiphora mukul, Curcuma longa,Camellia sinensis, Emblica officinalis, and Terminalis chebula; and

an effective amount of an omega 3 fatty acid or pharmaceuticallyacceptable or food grade acceptable derivative thereof.

Symptoms of one or more of the brain conditions where improvements maybe observed include, for example, speech articulation, includingcomplexity and sophistication of sentence structure; language skillssuch as improvements in the understanding of written and spoken wordand/or development of better reading and writing skills; fine and grossmotor skills including those related to multi-tasking abilities;imaginative play abilities; ocular and/or auditory focus includingawareness of surroundings; sensory awareness (in situations where sensorintegration dysfunction has been identified), non-verbal communicationskills such as facial expressions; task focus; socialization skills; andreduced levels or substantial elimination of seizures or headaches, thereduced levels of which may result in a lowering or elimination of anyseizure medication dosage levels deemed necessary. The improvement mayalso include normalization of EEG results.

While not desiring to be bound by any theory or theories of operation,it is believed that herbs like Emblica officinalis (amalaki), Curcumalonga (turmeric), Commiphora mukul, (guggul) and/or Gymnema may work onopening the micro circulatory channels and may also regulate variousendocrine pathways contributing to improved brain function. It isreasonably likely that there may be improved oxygenation to the brainand harmonious functioning of the right and left brain hemispheresbecause of reduced inflammation related to administration of such herbs.

In certain embodiments, the nutrient compositions are useful, interalia, in methods for enhancing cognitive function. In other embodiments,the nutrient compositions are useful, inter alia, in methods fortreating cognitive dysfunction.

In some embodiments, the invention relates to methods for enhancingcognitive function in patients by administering nutrient compositionsthat enhance one or more aspects of cognitive function, said nutrientcomposition comprising an effective amount of a mixture or purifiedmixture thereof comprising three or more botanical extracts selectedfrom the group of botanicals consisting of Gymnema sylvestre, Commiphoramukul, Curcuma longa, Camellia sinensis, Emblica officinalis, andTerminalis chebula. In certain preferred embodiments, the nutrientcomposition further comprises an effective amount of an omega 3 fattyacid or pharmaceutically acceptable or food grade acceptable derivativethereof.

“Cognitive function,” as used herein, refers to the function of themental process of a human or other animal, who may be unhealthy orunhealthy, and includes at least three different components: attention,learning, and memory. See, e.g., Mosby's Medical Dictionary, 5^(th)edition (1998); Stedman's Medical Dictionary, 11^(th) edition (1990). Incertain preferred embodiments of the invention, the method of theinvention are useful for enhancing cognitive function, particularlymemory, including enhancing the cognitive function, particularly memory,of a healthy or unhealthy patient. As used herein, “memory” refers tothe complex mental function having at least four distinct phases: (1)memorizing or learning, (2) retention, (3) recall, and (4) recognition,and includes immediate, recent, and remote memory. See, e.g., Mosby'sMedical Dictionary, 5^(th) edition (1998); Stedman's Medical Dictionary,11^(th) edition (1990).

The term “enhancing,” as used herein, refers to the ability of thecompounds of the invention and/or composition containing them toincrease the ability or capacity of an individual (healthy or unhealthy)to comprehend, judge, memorize, and reason; and can be measured bytypically employed by those skilled in the art. Such an improvement caninclude at least about a 10% increase, preferably, at least about a 25%increase, and more preferably, at least about a 50% increase.

In other embodiments, the patient is suffering cognitive dysfunction.“Cognitive dysfunction,” as used herein, refers to disturbances in themental process related to thinking, reasoning, and judgment andincludes, without limitation, memory loss. See, e.g., Mosby's MedicalDictionary, 5^(th) edition (1998); Stedman's Medical Dictionary, 11^(th)edition (1990). The term “cognitive dysfunction” indicates disruptionsin performance including one or more of the following signs:

-   -   (1) memory deficits (impaired ability to learn new information        or recall previously learned information;    -   (2) one (or more) of the following disturbances:        -   (a) aphasia (language disturbance)[        -   (b) apraxia (impaired ability to carry out motor activities            despite intact motor function)        -   (c) agnosia (failure to recognize or identify objects            despite in tact sensory function); and/or        -   (d) disturbance in executive functioning (i.e. planning,            organizing, sequencing, abstracting);    -   (3) memory disturbances causing significant impairment in social        or occupational functioning, and representing a significant        decline from a previous level of functioning; and    -   (4) impairment in cognitive functioning as evidenced by        neuropsychological testing or quantified clinical assessment,        accompanied by objective evidence of a systemic general medical        condition or central nervous system dysfunction.

Cognitive dysfunction is exhibited in certain diseases and disorders,including, but not limited to Alzheimer's Disease, mild cognitiveimpairment, age-related cognitive decline, vascular dementia,Parkinson's Disease dementia, amyotrophic lateral sclerosis,Huntington's Disease, stroke, traumatic brain injury, AIDS-associateddementia, schizophrenia, Lewy-body variant of Alzheimer's Disease withor without association with Parkinson's Disease, Creutzfeld-JakobDisease, Korsakoff's Disorder, learning disabilities caused bydegenerative disorders, learning disabilities caused by non-degenerativedisorders, genetic conditions (e.g., Rubenstein-Taybi Syndrome),cerebral senility, vascular dementia, electric shock induced amnesia,memory impairment associated with depression or anxiety, memoryimpairment associated with surgical procedures such as coronary arterybypass grafting (CABG), Down's syndrome, and combinations thereof.

In certain embodiments of the methods of the invention, the cognitivedysfunction is memory loss, including memory loss that isage-associated, caused by electro-convulsive therapy, the result ofbrain damage, or a combination thereof. The brain damage may be causedby a stroke, an anesthetic accident, head trauma, hypoglycemia, carbonmonoxide poisoning, lithium intoxication, vitamin deficiency (such asB1, thiamine and B12), or a combination thereof.

Memory loss and impaired learning ability are features of a range ofclinical conditions. For instance, loss of memory is the most commonsymptom of dementia states including Alzheimer's disease. Memory defectsalso occur with other kinds of dementia such as multi-infarct dementia(MID), a senile dementia caused by cerebrovascular deficiency, and theLewy-body variant of Alzheimer's disease with or without associationwith Parkinson's disease, or Creutzfeld-Jakob disease. Loss of memory isa common feature of brain-damaged patients. Brain damage may occur, forexample, after a classical stroke or as a result of an anestheticaccident, head trauma, hypoglycemia, carbon monoxide poisoning, lithiumintoxication, vitamin (B1, thiamine and B12) deficiency, or excessivealcohol use or Korsakoff's disorder. Memory impairment may furthermorebe age-associated; the ability to recall information such as names,places and words seems to decrease with increasing age. Transient memoryloss may also occur in patients, suffering from a major depressivedisorder, after electro-convulsive therapy (ECT).

Preferably, the nutrient compositions employed in the methods of thepresent invention are in granular or powder form; more preferablywherein the nutrient compositions are capable of being administeredorally; still more preferably wherein the nutrient composition iscombined with a liquid vehicle for oral consumption by the patient. Insome preferred embodiments, the liquid vehicle comprises water or milk.In other preferred embodiments, the liquid vehicle comprises juice.

In certain preferred embodiments, the nutrient composition comprises amixture or purified mixture thereof comprising botanical extractsselected from each of Gymnema sylvestre, Commiphora mukul, Curcumalonga, Camellia sinensis, Emblica officinalis, and Terminalis chebula.More preferably, the nutrient composition further comprises Cinnamomumverum or Capsicum annuum.

In other preferred embodiments the nutrient composition furthercomprises

(a) whey protein isolate, L-taurine, L-theanine, vitamin A (e.g., asretinol palmitate), vitamin B-1 (e.g., as thiamine mononitrate), vitaminB-2 (e.g., as riboflavin), vitamin B-3 (e.g., as niacinamide), vitaminB-5 (e.g., as d-ca pantothenate), vitamin B-6 (e.g., as pyridoxine HCl),vitamin B-7 (e.g., as biotin), vitamin B-9 (e.g., as folic acid),vitamin B-12 (e.g., as cyanocobalamin), vitamin C (e.g., as ascorbicacid), vitamin D-3 (e.g., as cholecalciferol), and vitamin E (e.g., asd-alpha tocopherol), brown rice powder, sugar, apple fiber, cocoapowder, xanthan gum, potassium gluconate, calcium lactate, stevia,iodine yeast, chromium yeast, manganese yeast, zinc gluconate, seleniumyeast, magnesium oxide, copper gluconate, and molybdenum yeast, and

(b) cocoa flavor and Capsicum annuum; or

vanilla flavor and Cinnamomum verum.

In some preferred embodiments, the nutrient composition furthercomprises one or more amino acids; more preferably wherein the aminoacids are in the form of one or more whey protein isolates. In even morepreferred embodiments, the one or more amino acids contained in theamino acid composition and/or contained in the one or more whey proteinisolates are selected from the group consisting of: alanine, arginine,aspartic acid, cysteine, cystine, glutamic acid, glycine, histidine,isoleucine, leucine, lysine, methionine, phenylalanine, proline, serine,threonine, tryptophan, tyrosine, and valine. In certain alternativelypreferred embodiments, the nutrient composition comprises each of theessential amino acids arginine, histidine, isoleucine, leucine, lysine,methionine, phenylalanine, threonine, tryptophanand valine.

While not desiring to be bound by any theory or theories of operation,it is believed that combinations of amino acids, preferably includingone or more essential amino acids, such as those in the commercialproduct NutriiVeda™, for example, may assist and support the healing ofneurotransmitter deficiency conditions such as seizures, depression,anxiety disorder, insomnia, Alzheimer's disease and/or Parkinson'sdisease.

In other preferred embodiments, the nutrient composition furthercomprises taurine or theanine; more preferably L-taurine or L-theanine.

In yet other preferred embodiments of the invention, the nutrientcomposition is gluten or casein free.

In certain preferred embodiments the nutrient composition furthercomprises at least one copper containing compound; more preferablywherein the nutrient composition comprises at least one coppercontaining compound and further comprises at least one additional metalcontaining compound, wherein the metal is selected from the groupconsisting of calcium, magnesium, zinc, selenium, manganese, chromium,and molybdenum. It may be advantageous in certain preferred embodimentsto incorporate one or more of the metals selected from the groupconsisting of calcium, magnesium, zinc, selenium, manganese, chromium,and molybdenum as their yeast complexes. Accordingly, in certain morepreferred embodiments, the selenium is provided as selenium yeast. Inother more preferred embodiments, the manganese is provided as manganeseyeast. In certain other more preferred embodiments, the chromium isprovided as chromium yeast. In still other more preferred embodiments,the molybdenum is provided as molybdenum yeast.

In some preferred embodiments, the nutrient composition furthercomprises vitamins, preferably sourced from whey protein, botanicals orother natural sources including nutritional yeast or other natural foodforms of vitamins.

In other preferred embodiments, the nutrient composition furthercomprises one or more vitamins; more preferably wherein the vitamin isselected from the group consisting of vitamin A, vitamin B-1 (thiamine),vitamin B-2 (riboflavin), vitamin B-3 (niacin), vitamin B-5 (pantothenicacid), vitamin B-6, vitamin B-7 (biotin), vitamin B-9 (folic acid),vitamin B-12, vitamin C, vitamin D-3, and vitamin E. In certain evenmore preferred embodiments, the one or more vitamins in an administereddose are present in the range of:

-   -   from about 2000 IU to about 3000 IU of vitamin A;    -   from about 1 mg to about 2 mg of vitamin B-1;    -   from about 1 mg to about 2 mg of vitamin B-2;    -   from about 10 mg to about 30 mg of vitamin B-3;    -   from about 5 mg to about 15 mg of vitamin B-5;    -   from about 1 mg to about 3 mg of vitamin B-6;    -   from about 10 mcg to about 50 mcg of vitamin B-7;    -   from about 200 mcg to about 600 mcg of vitamin B-9;    -   from about 2 mcg to about 10 mcg of vitamin B-12;    -   from about 30 mg to about 90 mg of vitamin C;    -   from about 200 IU to about 600 IU of vitamin D-3; and    -   from about 10 IU to about 50 IU of vitamin E.

In certain preferred embodiments the nutrient composition furthercomprises at least one protein source; more preferably wherein the atleast one protein source comprises brown rice powder.

In some other preferred embodiments the nutrient composition furthercomprises at least one source of sugars, dietary fiber, or othercarbohydrate.

In certain preferred embodiments, the nutrient composition containsother optional components, e.g., flavors or sweeteners to improvepalatability, and/or preservatives to improve shelf life.

Preservatives may be added to the nutrient compositions according to theinvention. Any suitable preservative can be employed, so long as thepreservative does not negate other desirable properties of the nutrientsupplements, or have undesirable side effects in persons (i.e., inautistic persons as compared with non-autistic persons). Preferredpreservatives include, but are not limited to, sodium benzoate andpotassium sorbate which can be obtained from any commercial supplier.Preferably these preservatives are of a high purity grade. For example,these preservatives can be obtained from Spectrum Quality Products, Inc.(Gardena, Calif, Catalog Numbers S1146 and P1408, respectively), or fromSigma-Aldrich (St. Louis, Mo., Catalog Numbers B3420 and S7420,respectively). Other appropriate preservatives are alcohol (from about15 to about 20%), benzoic acid (about 0.1%), methylparaben (from about0.025% to about 0.2%), propylparaben (from about 0.025% to about 0.2%),and sorbic acid (about 0.1%). Sodium benzoate and potassium sorbate (orother appropriate preservatives) also can be employed in the liquidformulations of the invention in amounts ranging from about 0.01% toabout 1.0% by weight (mass/volume, such as g/l) of the liquidformulations, even more preferably from about 0.05% to about 0.5% byweight (mass/volume), and especially from about 0.1% by weight(mass/volume).

Optionally, sweeteners may be added to the nutrient compositions of theinvention, for instance, to make the powder or liquid vehicle addedformulations more palatable, e.g., sweeteners such as natural sugars(e.g., glucose, sucrose, fructose) and synthetic sugars (e.g.,saccharin, cyclomates, Aspartame, etc.). In certain preferredembodiments, the nutrient compositions do not contain Aspartame or anyof its chemically analogous equivalents. Care must be taken with use ofnatural fructose sweeteners, however, since a high fructose content hasbeen suggested to exacerbate copper deficiency and to be associated withheart disease characterized by high triglyceride levels. Other preferrednatural sweeteners that can be employed in the invention, include butare not limited to: Bee Honey (Dutch Gold Honey, Lancaster, Pa.);Organic Bee Honey (miscellaneous vendors); Barley Malt syrups (BriessIndustries New York, N.Y.); deionized fruit juice (Daystar-Robinson,Lake Success, N.Y.); Fruitrim liquid (Adept Solutions); Brown ricesyrups (California Natural Products Santa Barbara, Calif.); Organicbrown rice syrup (California Natural Products); Oat syrup (T & AGourmet); Raw or Turbinado sugar (C & H sugar La Palma, Calif); Sucanat(Wholesome Foods Palm Bay, Fla.); Organic Sucanat (Wholesome Foods PalmBay, Fla.); Organic Sugar (Wholesome Foods Palm Bay, Fla.); Evaporatedcane juice (Florida Crystals Palm Beach, Fla.); and Ki-Sweet (kiwi fruitsweetener, marketed on the Internet), as well as other sweeteners. Theamount of sweetener effective in the supplement depends on theparticular sweetener used and the sweetness intensity desired, and canrange from about 0.1% to about 70%.

In certain other preferred embodiments the nutrient composition furthercomprises iodine. In more preferred embodiments, the iodine is providedas iodine yeast complex.

In other preferred embodiments, the nutrient composition does notfurther comprise at least one of the following moieties: adenosinemonophosphate, docosahexaenoic acid, and a sweetener containing75% to90% by weight of Lo Han Guo extract and 10 to 25% tagatose.

In certain alternatively preferred embodiments, the nutrient compositionoptionally further comprises less than 0.0002% by weight adenosinemonophosphate based on the weight of the nutrient composition.Alternatively, the nutrient composition optionally further comprisesmore than 0.010% by weight adenosine monophosphate and less than 10%based on the weight of the nutrient composition, preferably 2%, morepreferably less than 1%, with less than about 0.1% being even morepreferred.

In certain preferred embodiments, the nutrient composition comprisesnutrients derived from whole food sources or are in substantially thesame form, more preferably the same form, as found in whole foodsources.

It is believed the, compound names and abbreviations, as well as theplant extracts and biological names used herein correctly and accuratelyreflect the underlying compositions. However, the nature and value ofthe present invention does not depend upon the theoretical correctnessof these names and abbreviations, in whole or in part. Thus it isunderstood that the compound names and abbreviations, as well as theplant extracts and biological names attributed to the correspondinglyindicated compounds and extracts, are not intended to limit theinvention in any way, including local origins of plant species, orrestricting any compound, amino acid or component or mixture thereof toany specific tautomeric form(s) or to any specific optical or geometricisomer or mixture of isomers, except where such stereochemistry isclearly defined.

Although the nutrient compositions of the present invention may beadministered as the pure ingredient mixtures, it is preferable topresent the active ingredient mixture as a consumable composition. Theinvention thus further provides a consumable nutrient compositioncomprising, together with one or more carriers acceptable forconsumption therefor. The carrier(s) must be acceptable in the sense ofbeing compatible with the other ingredients of the composition and notdeleterious to the recipient thereof. Non-limiting examples includebrown rice powder, sugar, apple fiber, cocoa powder, and xanthan gum.

In addition to the food grade carrier, the extract(s) comprising thenutrient compositions of the present invention may be co-administeredwith at least one component comprising an omega 3 fatty acid, preferablyEPA (Eicosapentaenoic acid) or DHA (Docosahexaenoic acid), or anycombination thereof. The source of the fatty acid may be from animalfish, or plant origin and is typically derived from any of a number offish oils including anchovy, sardine, or mackerel or their mixtures.Other fish with elevated levels of omega 3 fatty acids include salmon,tuna, cod liver and/or herring. Other potent sources of omega 3 fattyacids include algae, such as microalgae (such as Crysthecodinium cohiiand Schizochytrium) and brown algae (kelp); and plankton. The omega 3fatty acid may be provided in a native or readily isolated form, or inany of the myriad of purified forms that may be provided, or may takethe form of a mixture of any one or more of the native, readily isolableor purified forms. In certain compositions the omega 3 fatty acid may beprovided in its free acid form, or a derivative thereof, including butnot limited to esters, especially purified esters; more preferably ethylor mono-, di-, or tri-ester forms of glycerine; or otherpharmaceutically or food grade acceptable derivatives known to theskilled artisan, including, for example pharmaceutically acceptablesalts of EPA or DHA. Among the most common n-3 fatty acids found innature are the following fatty acids: a-Linolenic acid (ALA),all-cis-7,10,13-hexadecatrienoic acid; Stearidonic acid (SDA),all-cis-6,9,12,15-octadecatetraenoic acid; Eicosatrienoic acid (ETE),all-cis-11,14,17-eicosatrienoic acid; Eicosatetraenoic acid (ETA),all-cis-8,11,14,17-eicosatetraenoic acid; (EPA),all-cis-5,8,11,14,17-eicosapentaenoic acid; Docosapentaenoic acid (DPA),all-cis-7,10,13,16,19-docosapentaenoic acid; Docosahexaenoic acid (DHA),all-cis-4,7,10,13,16,19-docosahexaenoic acid; Tetracosapentaenoic acid,all-cis-9,12,15,18,21-tetracosapentaenoic acid; and Tetracosahexaenoicacid (Nisinic acid), all-cis-6,9,12,15,18,21-tetracosahexaenoic acid.

It is further appreciated that while an omega 3 fatty acid or derivativethereof may be provided in purified form, it is often isolated inmixture with other fatty acids or their derivatives, including forexample, omega 6 fatty acids. The ratio of omega 3 to omega 6 fatty issaid to vary widely from source to source, for example, in canola oil(1:2); flaxseed oil (3:1); cold water fish oil (7:1) and in microalgae(22:6). Erasmus, Udo, Fats and Oils. 1986. Alive Books, Vancouver, p.263. Preferably, in combination products of the present invention thatinclude omega fatty acid components, preferably omega 6 fatty acidcomponents, in addition to omega 3 fatty acids, the ratio of omega 3 toomega other additional omega fatty acid components, preferably omega 6,is from about 1 to 1 to about 100:1, more preferably from about 2 to 1to about 50:1; still more preferably from about 3 to 1 to about 25 toabout 1 and all combinations and subcombinations of ranges of ratios ofomega 3 to omega 6 fatty acid components therein, wherein the ratios areexpressed as a ratio of the weights of the omega unsaturated acidcomponents.

In certain more preferred embodiments, the omega 6 fatty acid componentcomprises linolenic acid, still more preferably omega 6 gamma-linolenicacid (GLA), which may be provided in its free acid form, or a derivativethereof, including but not limited to esters, especially purifiedesters; more preferably ethyl or mono-, di-, or tri-ester forms ofglycerine; or other pharmaceutically or food grade acceptablederivatives known to the skilled artisan, including, for examplepharmaceutically acceptable salts of combination products of the presentinvention. Exemplary sources of GLA include for example borage seed oil(typically contains about 24% GLA) and primrose oil (typically containsabout 8 to about 10% GLA). These oils may be used as isolated from theirsources or further purified as recognized by those of ordinary skill inthe art. Alternatively preferred in some embodiments as an omega 6 fattyacid is dihomo-ã-linolenic acid (DGLA), a 20-carbon ù-6 fatty acid withthree cis double bonds; the first double bond is located at the sixthcarbon from the omega end. DGLA is the elongation product of ã-linolenicacid (GLA; 18:3, ù-6). The eicosanoid metabolites of DGLA includeSeries-1 thromboxanes (thromboxanes with 1 double-bond), via the COX-1and COX-2 pathways; Series-1 prostanoids, via the COX-1 and COX-2pathways.[1]; and a 15-hydroxyl derivative that blocks thetransformation of arachidonic acid to leukotrienes. See Fan, Yang-Yi andRobert S. Chapkin (9 Sep. 1998). “Importance of Dietary ã-Linolenic Acidin Human Health and Nutrition”. Journal of Nutrition 128 (9): 1411-1414;and Belch, Jill J F and Alexander Hill. “Evening primrose oil and borageoil in rheumatologic conditions”; American Journal of ClinicalNutrition, Vol. 71, No. 1, 352S-356S, January 2000. All of these effectsare reported to be anti-inflammatory, in marked contrast with theanalogous metabolites of arachidonic acid (AA), which are the series-2thromboxanes and prostanoids and the series-4 leukotrienes. In additionto yielding anti-inflammatory eicosanoids, DGLA competes with AA for COXand lipoxygenase, inhibiting the production of AA's eicosanoids.

Preferred compositions or preparations according to the presentinvention that include omega 3 fatty acid components may be prepared sothat an oral dosage unit form contains from about 100 to about 5000 mgof an omega 3 fatty acid, more preferably from about 100 to about 3000,still more preferably from about 100 to about 1000 mg of omega 3 fattyacid or pharmaceutically acceptable or food grade acceptable derivativethereof.

Co-administration of the omega 3 fatty acid with a nutrient compositionof the present invention may be provided by separate administration of asupplement comprising an omega 3 fatty acid at the same time orsequentially in any order at different points in time. Thus, eachcomponent may be administered separately but sufficiently closely intime so as to provide the desired therapeutic effect. Preferably, theomega 3 fatty acid is added to the nutrient composition for ease ofadministration. More preferably the nutrient composition is in powderedform. The omega 3 fatty acid in a fluid form is applied to or into thepowdered nutrient composition; or it may be mixed with the nutrientcomposition as a powdered form of an omega 3 fatty acid or derivativethereof. In preferable embodiments wherein the omega 3 fatty acid orderivative thereof is in powdered form, said powdered form is anencapsulated form of the fatty acid, preferably microencapsulated form.A non-limiting example of a powdered form of omega 3 fatty acid is anyone of a number of commercially available products, preferablymicroencapsulated omega 3 fatty acid compositions manufactured, sold,and/or distributed by Nordic Naturals, Inc., Watsonville, CA. Any powderform of an omega 3 fatty acid composition for use in or with any of theproducts of the invention has a density preferably similar to, morepreferably substantially the same as, the density of the powder form ofthe nutrient composition, at least in part to diminish or reducesettling of one of the powder components in the combination product. Thepreferential density of the omega 3 fatty acid (or derivative thereof)powder form may be inherent in the product or modified by any of a knownnumber of methods known to the skilled artisan.

The omega 3 fatty acid combination products (products comprisingnutrient compositions with added omega 3 fatty acid) of the presentcompositions may further include one or more other active ingredientsthat may be conventionally employed in nutrient composition products.

The nutrient compositions of the invention may be orally administered inan effective amount by any of the conventional techniqueswell-established in the medical field. The nutrient compositions of theinvention may also be orally administered in an effective amount bycombining the composition with one or more food or beverage products andadministering the combination.

The compositions may be administered alone or may be combined with aconsumable carrier selected on the basis of the chosen route ofadministration The relative proportions of active ingredient and carriermay be determined, for example, by the solubility and chemical nature ofthe ingredients in the nutrient composition, chosen route ofadministration and standard practice for food consumables.

Nutrient compositions as described herein may be orally administered toa mammalian host in a variety of forms adapted to the chosen route ofadministration.

The nutrient compositions may be orally administered, for example, withan inert diluent or with an assimilable edible carrier, or it may beenclosed in hard or soft shell gelatin capsules, or it may be compressedinto tablets, or it may be incorporated directly with the food of thediet. For oral therapeutic administration, the active nutrientcomposition may be incorporated with excipient and used in the form ofingestible tablets, buccal tablets, troches, capsules, elixirs,suspensions, syrups, wafers, and the like. The amount of active nutrientcomposition in such therapeutically useful compositions is preferablysuch that a suitable dosage will be obtained. Preferred compositions orpreparations according to the present invention may be prepared so thatan oral dosage unit form contains from about 0.1 to about 5000 mg ofthree or more active botanical extracts selected from the group ofbotanicals consisting of Gymnema sylvestre, Commiphora mukul, Curcumalonga, Camellia sinensis, Emblica officinalis, and Terminalis chebula,and all combinations and subcombinations of ranges and specific amountsof active botanical extract therein.

The tablets, troches, pills, capsules and the like may also contain oneor more of the following: a binder, such as gum tragacanth, acacia, cornstarch or gelatin; an excipient, such as dicalcium phosphate; adisintegrating agent, such as corn starch, potato starch, alginic acidand the like; a lubricant, such as magnesium stearate; a sweeteningagent such as sucrose, lactose or saccharin; or a flavoring agent, suchas peppermint, oil of wintergreen or cherry flavoring. When the dosageunit form is a capsule, it may contain, in addition to materials of theabove type, a liquid carrier. Various other materials may be present ascoatings or to otherwise modify the physical form of the dosage unit.For instance, tablets, pills, or capsules may be coated with shellac,sugar or both. A syrup or elixir may contain the active compound,sucrose as a sweetening agent, methyl and propylparabens aspreservatives, a dye and flavoring, such as cherry or orange flavor. Ofcourse, any material used in preparing any dosage unit form ispreferably pharmaceutically pure and substantially non-toxic in theamounts employed. In addition, the active peptide may be incorporatedinto sustained-release preparations and formulations.

The dosage of the nutrient composition of the invention may varydepending upon various factors such as, for example, the pharmacodynamiccharacteristics of the particular agent and its mode and route ofadministration, the age, health and weight of the recipient, the natureand extent of the symptoms, the kind of concurrent treatment, thefrequency of treatment, and the effect desired. Generally, small dosagesmay be used initially and, if necessary, increased by small incrementsuntil the desired effect under the circumstances is reached.

Although the proper dosage of the nutrient compositions of thisinvention will be readily ascertainable by one skilled in the art, oncearmed with the present disclosure, typically a dosage of the nutrientcomposition of the invention, preferably a nutrient compositioncomprising an effective amount of a mixture or purified mixture thereofcomprising three or more botanical extracts selected from the group ofbotanicals consisting of Gymnema sylvestre, Commiphora mukul, Curcumalonga, Camellia sinensis, Emblica officinalis, and Terminalis chebula,still more preferably wherein the nutrient composition comprises each ofthe botanical extracts selected from the group of botanicals consistingof Gymnema sylvestre, Commiphora mukul, Curcuma longa, Camelliasinensis, Emblica officinalis, and Terminalis chebula. In certainpreferred embodiments wherein NutriiVeda™ weight management shakes (asprovided by Zrii®, LLC of Draper, Utah 84020) are used as the nutrientcomposition, the proper dosage may range from about 2 to 4 grams per dayup to about 20 grams a day (may be split into half dosages twice a day)for patients in the age range of from birth to about three years. Forthose aged about four to about eight years, the dose may range fromabout 20 grams to about 40 grams a day (may be split into half dosagestwice a day). For patients of from about nine years to adult, a typicaldose is up to about 85 grams to about 125 grams a day, preferably splitinto 40-65 grams per serving. Preferably, initial administration of thecomposition is at about 20 grams increased to about 25 grams per day. Insome instances, qualified medical personnel have employed higherdosages, such as with 3 year old children up to about 40 grams overtime, with children between 4 and 8 up to about 65 grams over time.

The dose may also be provided by controlled release of the compound, bytechniques well known to those in the art, such as microencapsulation.Microencapsulation is a preferred means of providing an omega 3 fattyacid or derivative thereof with or within compositions of the presentinvention, especially for those that may be administered in thetreatment or inhibitions of apraxia, autism, speech impairments,traumatic brain injury, seizure disorders, epilepsy, global delays, orADHD or any combination thereof.

The nutrient compositions may be mixed with any type of milk, juice, orwater. However, it is preferable to mix the composition with theselected liquid vehicle at temperatures below about 100° C., morepreferably below about 50° C., more preferably still at about roomtemperature and below to minimize any possible adverse affect on potencyof the composition. The composition can also be mixed with ice cream orsimilar semi-frozen beverage.

A wide variety of food vehicles may be employed to assist inadministration of the nutrient composition, such as yogurt, pudding,apple sauce, ketchup, ranch dressing or cake frosting. Some parents havesprinkled it over pancakes or cereal including oatmeal.

The nutrient compositions of the present invention preferably cancontain other natural and man-made compounds such as would beappropriate for a particular application, e.g., other carriers,stabilizers, preservatives, active agents, etc., so long as these othercompounds do not negate the desirable properties of the nutrientcompositions. In particular, tablets optionally may contain suitablebinders, lubricants, diluents, disintegrating agents, coloring agents,flow-inducing agents, melting agents, and the like. Liquid formulationsoptionally may contain suitable solvents, emulsifying agents, suspendingagents, diluents, melting agents, coloring agents, and the like. Ofcourse, any component that detracts from or negates the desirablebenefits of other components present in the nutrient compositions, orwhich has negative effects in the persons being treated (e.g., autisticpersons or persons predisposed to autism as compared with non-autisticpersons or non-predisposed persons) should not be employed.

In certain preferred embodiments the nutrient composition for use in themethods of the present invention comprises any one of NutriiVeda™ weightmanagement shake compositions provided by Zrii®, LLC of Draper, Utah.

Kits useful in, for example, for the treatment of apraxia, autism, TBI,global delays, ADHD, which comprise a therapeutically effective amountof a nutrient composition of the invention in one or more sterilecontainers are also within the ambit of the present invention. Kitsuseful in, for example, for the treatment of stroke, or seizurescomprising a therapeutically effective amount of a nutrient compositionof the invention in one or more sterile containers are also within theambit of the present invention. Kits useful in, for example, forenhancing cognition, which comprise a therapeutically effective amountof a nutrient composition of the invention in one or more sterilecontainers are also within the ambit of the present invention.Sterilization of the container may be carried out using conventionalsterilization methodology well known to those skilled in the art. Thesterile containers of materials may comprise separate containers, or oneor more multi-part containers. Instructions, either as inserts or aslabels, indicating quantities of the components to be administered,guidelines for administration, and/or guidelines for mixing thecomponents, may also be included in the kit.

It will be further appreciated that the amount of the nutrientcomposition required for use in treatment will vary not only with theparticular composition selected but also with the nature of thecondition being treated and the age and condition of the patient, andwill be ultimately at the discretion of the attendant administering thecomposition.

The desired dose may conveniently be presented in a single dose or asdivided doses administered at appropriate intervals, for example, astwo, three, four or more sub-doses per day.

In certain preferred aspects, the methods comprise the step ofadministering to said patient an effective amount of a nutrientcomposition.

The nutrient compositions of the present invention may be utilized in anumber of ways. In certain embodiments, the nutrient compositions areuseful, inter alia, in methods for treating apraxia, autism, traumaticbrain injury, global delays, or ADHD, or any of the related symptoms ofapraxia, autism, traumatic brain injury, global delays, or ADHD.

Thus, in accordance with preferred aspects of the invention, there areprovided methods of preventing or treating apraxia, autism, speechimpairments, traumatic brain injury, seizure disorders, epilepsy, globaldelays, or ADHD, or any of the related symptoms of apraxia, autism,speech impairments, traumatic brain injury, seizure disorders, epilepsy,global delays, or ADHD.

In certain embodiments, the nutrient compositions are useful, interalia, in methods for treating stroke.

Thus, in accordance with preferred aspects of the invention, there areprovided methods of preventing or treating stroke, or any of the relatedsymptoms of stroke.

When any variable occurs more than one time in any constituent or in anycomposition, its definition in each occurrence is independent of itsdefinition at every other occurrence.

The invention illustratively disclosed herein suitably may be practicedin the absence of any element which is not specifically disclosedherein. The invention illustratively disclosed herein suitably may alsobe practiced in the absence of any element which is not specificallydisclosed herein and that does not materially affect the basic and novelcharacteristics of the claimed invention.

The present invention will now be illustrated by reference to thefollowing specific, non-limiting examples. Those skilled in the art oforganic synthesis may be aware of still other synthetic routes to theinvention peptides. The reagents and intermediates used herein arecommercially available or may be prepared according to standardliterature procedures. These examples are for illustrative purposesonly, and are not to be construed as limiting the appended claims.

EXPERIMENTAL SECTION

The following procedures may be employed as a manner of measuringqualitative and/or quantitative effects that result from administrationof various nutrient compositions of the present invention to a patientin need thereof, including effects such as behavioral modifications,cognition enhancement and/or anti-convulsant activity

Evaluation of Principal Effects of Compositions of the Present Invention

Principal effects of a composition of the present invention may beevaluated using the Primary Observation (Irwin) Test in the mouse. SeeIrwin (Psychopharmacologia, 13, 222-257, 1968). This method detects thefirst toxic dose, the active dose-range and the principal effects of atest substance on behavior and physiological function. Mice areadministered the test substance and are observed in simultaneouscomparison with a control group given vehicle (non-blind conditions).Between 1 and 3 treated groups are compared with the same control at anyone time. All animals within a treatment group are observedsimultaneously.

Behavioral modifications, physiological and neurotoxicity symptoms,rectal temperature and pupil diameter are recorded according to astandardized observation grid derived from that of Irwin. The gridcontains the following items: death*, convulsions*, tremor*, Straubtail*, altered activity, jumping*, abnormal gait* (rolling, tiptoe),motor incoordination*, altered abdominal muscle tone, loss of grasping,akinesia, catalepsy, loss of traction, writhing*, piloerection*,stereotypies* (sniffing, chewing, head movements), head-twitches*,scratching*, altered respiration*, aggression*, altered fear/startle,altered reactivity to touch, ptosis, exophthalmia, loss of rightingreflex, loss of corneal reflex, analgesia, defecation/diarrhea,salivation, lacrimation, rectal temperature (hypothermia/hyperthermia)and pupil diameter (myosis/mydriasis).

Observations are performed 15, 30, 60, 120 and 180 minutes afteradministration of the test substance and also 24 hours later. Thesymptoms marked (*) are observed continuously from 0 to 15 minutes afteradministration.

Raw data are entered into calculation spreadsheets. All data entered arecompared with raw data by two persons to verify entry accuracy beforedata analysis.

In grouped data tables: qualitative data are presented aspresence/absence, or decrease/increase, of the behavioural symptoms.Rectal temperature and pupil diameter are measured quantitatively andare presented as means followed by ± sign and the standard error of themean (s.e.m.) and as variation (delta) from control at each time point.

In summary tables: qualitative data are presented as the number ofanimals showing the symptoms (with their intensity (slight, moderate ormarked) for decrease or increase in movements). Rectal temperature andpupil diameter are graded on a 3-point scale (slight, moderate ormarked) in terms of the direction change from control values.

Evaluation of Cognition Enhancing Activity Using the Social RecognitionTest in the Rat (Delay Induced Deficit)

Memory or cognition enhancing activity may be measured following theprocedure described by Lemaire et al. (Psychopharmacology, 115, 435-440,1994). As one way of estimating cogntition enhancement, compositions ofthe present invention are tested as follows:

An unfamiliar juvenile is introduced into the individual home cage of amature adult rat for 5 minutes. Following this first contact (C1), thejuvenile is returned to its isolation cage for 120 minutes andreintroduced for a second contact of 5 minutes with the same matureadult rat (C2).

The time the adult rat spends investigating (sniffing, grooming,licking, closely following) the juvenile at each contact is recorded. Arecognition index (=C2/C1) is also calculated. Under such conditions, amature adult rat failure to recognize the juvenile as familiar isindicated by an absence of reduction in the duration of socialinvestigatory behavior at C2.

The test substances are evaluated at 2 doses, administered p.o.immediately after before Cl (i.e. 120 minutes before C2), and comparedwith a vehicle control group. The test is performed blind. Donepezil HCl(3 mg/kg i.p.) administered immediately after Cl is used as referencesubstance.

Data are analyzed by comparing treated groups with control using one-wayAnova followed by post-hoc analysis.

Raw data are entered into calculation spreadsheets previously verifiedand protected using a standard commercial spreadsheet product. All dataentered are compared with raw data by two to verify entry accuracybefore data analysis. Results in grouped data tables or figures arepresented as means followed by a ± sign and the standard error of themean (s.e.m.) (parametric data) or as medians followed by [interquartileranges] (non-parametric data). All differences are consideredstatistically significant when the null hypothesis can be rejected at arisk a of less than 0.05.

Evaluation of Anticonvulsant Activity for Compositions of the PresentInvention Using the 6 Hz Psychomotor Test in the Mouse

Anticonvulsant activity may be measured by the following method asdescribed by Brown et al. (J. Pharmacol. Exp. Ther. 107, 273-283, 1953),which detects anticonvulsant activity.

Mice are administered a rectangular current (44 mA, rectangular pulse:0.2 ms pulse width, 3 s duration, 6 Hz) via corneal electrodes connectedto a constant current shock generator (Ugo Basile: Type 7801). Theresults for the number of seizures as reflected by forelimb clonus andStraub-tail are recorded during the first minute following currentadministration. Forelimb clonus is scored as absent (0), mild (1) andstrong (2) whereas Straub tail is rated as absent (0) or present (1). 15mice are studied per group. The test is performed blind.

Each composition is evaluated at 2 doses, administered p.o. 60 minutesbefore the test and compared with a vehicle control group. Diazepam (8mg/kg p.o.), administered under the same experimental conditions, isused as reference substance.

Quantitative data (scores) with the tested compositions are analyzed bycomparing treated groups with vehicle control using the Kruskal-Wallistest followed by the Mann-Whitney U test. Quantitative data with thereference substance are analyzed using the Mann-Whitney U test.

Quantal data (Straub tail) will be analyzed by comparing treated groupswith the vehicle control using Fisher's Exact Probability tests.

The examples that follow are directed to in vivo experiments in humanswhich demonstrate the effectiveness of the methods of the presentinvention. They represent anecdotal reports gathered from parents and/orattending physicians regarding improvements in patients attributed toadministration of NutriiVeda™, a nutrient composition that isadministered in certain preferred embodiments of the present invention.

EXAMPLE 1

A nine year old male patient was administered 2 scoops (approximately 40grams) of NutriiVeda™ on a once per day basis. Prior to administration,the patient had been having uncontrolled seizures for three years inspite of continuing administration of seizure medications. Soon afteradministration was begun, slight improvements in mood, temper, andlanguage comprehension were observed. Dosage was increased toapproximately 40 grams twice per day basis. The patient was seizure-freefor 15 weeks and the dosage level of his seizure medication was reducedon two occasions.

EXAMPLE 2

A 4 ½ year old male patient was diagnosed with high functioning autismand severe oral and verbal apraxia (also a milder limb apraxia). Thepatient was administered 2 scoops (approximately 40 grams) ofNutriiVeda™ on a once per day basis. After two weeks, the improvementsin written language recognition and related speech were observed. Thepatient began spelling out words after week 3 and counting up to 10.

EXAMPLE 3

A thirteen year old male patient diagnosed with apraxia showedimprovements in speech after administration of 2 scoops (approximately40 grams) of NutriiVeda™) on a twice per day basis. After one week thepatient's language was observed to be smoother and faster. At a latertime, administration of NutriiVeda™ was reduced to 2 scoops(approximately 40 grams) of NutriiVeda™) at breakfast on one day and 2scoops (approximately 40 grams) of NutriiVeda™) the next night. Theparent noticed that the patient's speech had regressed at the end ofthis period of reduced administration. Administration was increased toearlier levels and subsequently increased to 3 scoops (approximately 60grams) of NutriiVeda™) on a twice per day basis. In the weeks thatfollowed the patient's speech improved. Additionally the patient beganwaking up each morning prior to his alarm, showed greater interest inreading and sharing the books he was reading (in detail), read a chapterbook in two days, had a sudden ability to independently blink one eye ata time. The male patient's chief school administrator confirmed that wasmore alert, participated more in class and showed improved speechabilities.

EXAMPLE 4

A male child patient diagnosed with apraxia at three years of age wasinitially administered 1 scoop (approximately 20 grams) of NutriiVeda™on a once per day basis with a gradual increase to two scoops(approximately 40 grams) per day over a one month period. The attendingspeech language pathologist subsequently indicated that the patientshowed fewer signs of classic apraxia and noted that the patient'sapraxia symptoms have been reduced such that they now more resemble aphonological processing. After one month of taking NutriiVeda™, thepatient's word usage, conversation skills, language comprehension andfine motors skill levels improved.

EXAMPLE 5

A speech language pathologist from Marriottsville, MD reported thefollowing observations regarding a client diagnosed with apraxia.

A six year old male patient diagnosed with global apraxia w/fine motorand sensory challenges was administered 1 scoop (approximately 20 grams)of NutriiVeda™ in a chocolate pudding delivery vehicle on a once per daybasis. Subtle changes in fine motor skills were observed such as writinghis name by connecting the dots; greater willingness to try school workand practice (many more attempts to imitate words in isolation and incombination); multitasking-today during play; and displaying a sense ofhumor while using his words

EXAMPLE 6

A 34 month old male patient was diagnosed with Childhood Apraxia ofSpeech at 24 months. He was administered 1 scoop (approximately 20grams) of NutriiVeda™) on a once per day basis. After five days thepatient's mood and demeanor improved and resistance to parentalinstruction decreased. The patient demonstrated improved peace/calmness.His verbal language skills showed more complex language use, and thepatient's articulation of consonants was much clearer and completion ofword end sounds was enhanced relative to his efforts prior toadministration. His abilities to focus for extended periods wereenhanced. His therapist has noted that the patient is making soundseasier and that his focus was significantly better.

EXAMPLE 7

A 5 year old male patient was diagnosed with Childhood Apraxia ofSpeech. He was administered 1.5 scoops (approximately 30 grams) ofNutriiVeda™) on a twice per day basis. The patient drank a glass ofwater prior to administration of the NutriiVeda™. Initially theNutriiVeda™ was mixed with DariFree chocolate. Subsequently, theDariFree chocolate was substituted by water. Within six weeks, thepatient required much less translation from a parent to communicate withothers. In addition, the patient increased his standard score from 69 to89 on the Goldman Fristoe Test of Articulation. The patient also showedimprovement in behavior, song singing, and motor skills. Uponre-evaluation by a neurologist, his diagnosis was downgraded from severeapraxia to mild to moderate apraxia, extending to limbs.

EXAMPLE 8

A nine year old male patient diagnosed with severe apraxia, mildPDD/NOS, and seizure disorder was scheduled for a partial lobotomy. Thepatient was administered 2 scoops (approximately 40 grams) ofNutriiVeda™ on a twice per day basis. Prior to administration, thepatient had been having uncontrolled seizures with a periodicity of lessthan or equal to 2 weeks. Within 2 to 3 weeks of the initial ofNutriiVeda™ administration, slight improvements in articulation, overallintelligibility, more sophisticated use of language, awareness ofsurroundings, and spontaneity of speech were observed. The patient hasbeen seizure-free for 9 months at this dosage level. In view of the lackof seizures, the surgery was postponed indefinitely and the patient wastaken off the seizure control medications Depakote and Corbotrol.

Subsequently, the parent reduced dosage of the nutrient composition inhalf for several months. The child's SLP noticed a reduction in earlierspeech/language gains. The parent then discontinued NutriiVeda™ forabout two weeks to give her son a “break” from administration. Shortly(about 3 days) after reinitiating administration of the composition, thepatient had his first seizure in over a year.

EXAMPLE 9

A six and one half year old male patient predisposed to seizures anddiagnosed with severe apraxia, autism/PDD and hypotonia, seizuredisorder was administered 2 scoops (approximately 40 grams) ofNutriiVeda™ on a twice per day basis for one week. The dosage wasincreased to 3 scoops (approximately 60 grams) of NutriiVeda™ on a onceper day basis thereafter. After administration was begun, improvementsin speech skills, social skills, awareness of surroundings, gross andfine motor skills and mood were observed. There was a decrease in thefrequency/and/or severity of seizures leading to a decrease inadministration levels of Topomax (for seizures) and Clonadine (for sleepassistance).

EXAMPLE 10

A 10 year old female patient diagnosed with severe apraxia/dyspraxia andsevere autism/PDD and predisposed to seizures was administered 2 to 4scoops (approximately 40 to 80 grams) of NutriiVeda™ split up during theday. The dosage was provided as a shake with milk, or frozen into apopsicle or ice cream. Prior to administration, the patient had beenhaving uncontrolled seizures even while sleeping despite continuingadministration of seizure medication. After four weeks of NutriiVeda™administration, improvements in articulation, intelligibility, oralmotor skills, vocabulary gross and fine motor skills, focus, and moodwere observed. The intensity and frequency of seizures has subsided.

EXAMPLE 11

A 2 year old female patient diagnosed with apraxia and hypotonia wasadministered 1 scoop (approximately 20 grams) of NutriiVeda™ split upduring the day. The dosage was provided as a shake with milk. After 4weeks, improvements in sound production, articulation, overallintelligibility, motor planning, vocabulary, gross and fine motorskills, multi tasking, focus and mood were observed.

EXAMPLE 12

A 3 year old male patient diagnosed with severe apraxia and gross andfine motor skill delays was administered 1 scoop (approximately 20grams) of NutriiVeda™ split up during the day for two weeks. The dosagewas provided as a shake with milk. After 2 weeks, improvements in soundproduction, articulation, overall intelligibility, social skills,learning skills, multi tasking, focus and mood were observed.

EXAMPLE 13

A 4 year old male patient diagnosed with moderate autism/PDD wasadministered 1 scoop (approximately 20 grams) of NutriiVeda™ on a onceper day basis. The dosage was provided as a shake with milk. Slightimprovements were noted within 3 to 5 days. After 6 weeks, improvementsin sound production, oral motor dysfunction, receptive language skills,expressive language skills, social skills, gross and fine motor skills,multi tasking, focus and mood were observed.

EXAMPLE 14

A 3 year old male patient diagnosed with severe apraxia and dysarthria(weakness of facial muscles) was administered 1 scoop (approximately 20grams) of NutriiVeda™ on a once per day basis. The dosage was providedas a shake with milk. After 2 weeks, improvements in sound production,articulation, overall intelligibility, oral motor dysfunction, receptivelanguage skills, expressive language skills, social skills, fine motorskills, learning skills, multi tasking, focus and mood were observed.

EXAMPLE 15

A 10 year old male patient diagnosed with severe apraxia, motor planningan sensory dysfunction was administered 2 scoops (approximately 40grams) of NutriiVeda™ on a twice per day basis for five weeks. Thedosage was provided as a shake with milk or juice, or mixed in apudding, yogurt, applesauce, or peanut butter food vehicle. Slightimprovements were noted within 3 to 5 days. After 5 weeks, improvementsin sound production, articulation, overall intelligibility, motorplanning, receptive language skills, expressive language skills, socialskills, learning skills, fine motor skills, multi tasking, focus andmood were observed.

EXAMPLE 16

A 3 year old male patient diagnosed with mild apraxia, feeding andswallowing disorders, and sensory integration dysfunction wasadministered 1 scoop (approximately 20 grams) of NutriiVeda™ split upover the day for four weeks. The dosage was provided as a shake withjuice. Slight improvements were noted within 3 to 5 days. After 5 weeks,improvements in sound production, articulation, overall intelligibility,expressive language skills, social skills, fine motor skills, focus andmood were observed.

EXAMPLE 17

An eighty nine year old male patient was diagnosed with Alzheimer's 9years previously. His condition had progressed to a point where he wasunaware of his surroundings, unable to care for himself, unable to walkwithout falling, and unable to speak. He was being considered as anursing home resident based on his needed care requirements. Hiscaregiver began administering 1 scoop (approximately 20 grams) ofNutriiVeda™ four times a day (total of 4 scoops) and at times up to sixtimes a day thereafter. Improvements in speech skills were noted withinone day after the onset of NutriiVeda™ administration. Within a monththe patient showed observable improvements in lucid conversation,awareness of surroundings, personal care, and ability to walk withoutfalling as noted by the family and the patient's doctor. Therecommendation for nursing home admittance was withdrawn.

EXAMPLE 18

A thirty five year old male was diagnosed with severe stroke in the lefthemisphere right in the speech center of the brain from a severedcarotid artery. While under induced coma, part of his skull was removedfor brain swelling. Shortly after returning home to continue hisrecovery, his mother began to administer one scoop/day of NutriiVeda™.His mother observed a reduction followed by an absence of the patient'ssevere headaches. The mother subsequently increased her son's dosage tofour scoops a day. At the time that the increased dosage was initiated,the patient's speech was 23% intelligible. It was his doctor's prognosisat that time that the patient would never again be able to speak clearlybased on the location in the brain where the stroke occurred and itseffect on that brain region. To the contrary, the patient had rapidimprovements including in his speech. In four months, his speechintelligibility rose to 82%. He had other noted improvements inmovements to his right arm and leg relative to his earlier paralyticstate.

EXAMPLE 19

A six and a half year old male was diagnosed with severe autism, mentalretardation, medication resistant epilepsy (Grand Mal seizures) andhypotonia. He had been under the care of the same neurologist all hislife and was on three medications, two for seizures and one for sleep.Prior to the time he was administered NutriiVeda™, he made essentiallyno gains in any area in is IEP goals and was in a wheelchair, unable toperform even simple skills. He was put on somewhat less than 4 scoops ofNutriiVeda™ daily for over a year. Within the first month, he started toplay, smile, and climb, and became curious about his surroundings. Hebegan to act like a normal child. Within the first six months of beingon his daily regimen of NutriiVeda™ he was taken off all three of hismedications and remains seizure free with no sleep issues. He met allhis goals on his IEP and new aggressive goals were set for him. Hislong-time neurologist from Kaiser Permanente Santa Clara Medical Centerstated he has two other patients with similar characteristics that wereadministered NutriiVeda™ with similar results.

EXAMPLE 20

Five year old female was diagnosed with severe autism, hypotonia, globaldelays, and chronic constipation. Numerous therapies and strategies aswell as special diets had been tried with little or no positive results.She was administered a regimen of two scoops of NutriiVeda™ per day.Within one week she began playing with a doll and other toys that hadall been previously ignored. She also took an interest in an iPad™ andstarted playing some age and/or skill appropriate computer games on herown. She subsequently developed motor skills sufficient to carry hertoys and iPad up to and into a chair to play which was previousimpossible for her without assistance. She also began to walk around thehouse unassisted. She became openly affectionate for the first time. Shewas also able to move her bowels for the first time on her own.

EXAMPLE 21

A fifteen year old male with autism and mental retardation was put on aregimen of four scoops a day of NutriiVeda™. Prior to beginning thisregimen, his IQ was 47. Within 3 months he began to perform skills thathe was unable to perform previously, such as removing a carton of milkfrom the refrigerator on his own and pouring himself a glass of milk.After 3 months on his regimen of NutriiVeda™, his IQ improved to 62.

EXAMPLE 22

A sixteen year old male was diagnosed with ADHD. His high schoolreported that his focus was poor and he was floundering in his grades.He was put onto four scoops of NutriiVeda™ per day. Almost immediateimprovements were noted in his focus. There were also improvements notedin his maturity, social skills and communication. His parents receivedcertificates from three of his teachers in recognition of improvement inhis abilities at school. He maintained these improvements on a regularregimen of from two to four scoops per day and is currently a straight Astudent.

EXAMPLE 23

A thirty seven year old woman, mother of four, was diagnosed four yearsago with partial absence seizures due to a lesion in her right fronttemporal lobe caused by radiation treatment for cancer. She was neverseizure free for more than three days. She self-administered NutriiVeda™on a one scoop per day regimen for one month. During this time she wentfor 12 days without a seizure. When she ran out of Nutriiveda shedecided to stop her regimen and her seizures began again. Once shereinitiated her administration of NutriiVeda™, her seizures stopped.Subsequently, she administered NutriiVeda™ each day for 4 months on aone scoop per day regimen. She then voluntarily stopped takingNutriiVeda™ and has remained free of seizures (one month so far).

EXAMPLE 24

A four and a half year old girl was diagnosed with global delays, wasstill unable to walk, and had medication-resistant Grand Mal seizures.She was put on a NutriiVeda™ administration schedule of two scoops aday. Within one week she was able to walk across a room and has stoppedhaving seizures. After six months on her regimen, she is both walkingand talking and has remained seizure free.

EXAMPLE 25

A male aged 4 years and nine months was diagnosed as mosaic with apartial duplication on Chromosome 19 has been on both fish oils andNutriiVeda™ for about one year. One year ago, he started a regimen ofProEFA fish oils (one capsule a day). Within three weeks he went fromsaying “cu” to “cup”. Within a few months started putting a few simpletwo word sentences together such as “go bye” however most of his speechwas still limited to single word utterances. Subsequently he started aregimen of NutriiVeda™ in combination with the fish oil capsules. Withindays his speech improved both in clarity and in length of sentenceswhich was observed by professionals that worked with him. Theprofessionals indicated that it was like a “fog was clearing” in thepatient's brain. Within one month of starting NutriiVeda™ at one scoop aday together with his one capsule of ProEFA fish oil he started ridinghis tricycle for the first time. Six months later his mother increasedhis dosage of NutriiVeda™ to two scoops and again within days his speechincreased to eight word sentences such as “I want a cup of apple juice,mama” While over the next four months the most dramatic improvements wasin speech, he continued progress in fine and gross motor skills as well.One area that had not improved was his stimming; jumping and rubbing hisfingers together when he was excited. His dosage of NutriiVeda™ wasraised to three scoops per day. Shortly thereafter, he developed anability to control his stimming for the first time.

EXAMPLE 26

A male aged 3 years and 10 months who was diagnosed with apraxia was puton one scoop of NutriiVeda™ per day regimen. Previous to takingNutriiVeda™, he was essentially nonverbal, non compliant in therapy,lacking in social skills, with no interest in any books, spelling orcounting. During the first week of being on NutriiVeda™ he started totalk and develop more appropriate social skills. Within the first monthhe started speaking in understandable 3 and 4 word sentences anddeveloped an interest in books, spelling, and writing his name. After amonth, the regimen was revised to include one capsule a day of ProEFAfish oils (manufactured by Nordic Naturals). Within a week he increasedup to 9 word sentences. For example to his grandmother whom he calls“Momo”, the male patient said “Momo, I luv you to moon to you home.”After starting back to school and being without speech therapy for threemonths (summer holiday), he started back to preschool and both theteacher as well as the principal were elated over his progress. While itis typical that children with apraxia regress without instruction overthe summer months, the speech therapist noted significant improvement inthis case and documented that the patient's speech was easier tounderstand and that he was answering questions in the classroom.

EXAMPLE 27 Improvement in Cognitive Function and Academics Case

A seventeen year old female senior high school student was put on on aregimen of 4 scoops of NutriiVeda™ split up during the day. Prior to thestart of this regimen, her grades were primarily Bs and Cs. In socialsettings among peers, she showed symptoms of anxiety and insecurity.Almost immediately, her mother reported that her daughter seemed moremotivated to do her school work. As the weeks progressed, she expressedinterest in improving her grade point average. By the end of that schoolsemester (about 3 months later), she was a straight A student. Shebecame easy going and sociable with her peers, joining after schoolactivities such as theater. After high school graduation, she wasaccepted into the Academy of Art University in San Fransisco where shemajored in theater. She has continued to do well academically on herNutriiVeda™ regimen of 4 scoops per day.

EXAMPLE 28

Improvement in Cognitive Function and Academics Case

A fourteen year old male was put on a regimen of 4 scoops of Nutriivedasplit up during the day. Prior to the start of this regimen, his gradeswere Bs and Cs. His parents' main concern was lack of popularity amongother students in the school. He was teased and insecure. Within weeksof being on NutriiVeda™ he appeared to be more confident. He became moreoutgoing at school and started joining after school activities andmaking new friends. His mother described it as “suddenly came out of hisshell.” That semester his grades went from Bs and Cs to solid As andwithin a year of being on NutriiVeda™ he was asked to join the NationalHonors Society. This past summer, he saved up his own money to pay for asummer math class that enabled him to take more AP classes in highschool this year. He ran for class president this year at school andwon.

[Embodiment 1] A method for treating apraxia, autism, speechimpairments, traumatic brain injury, seizure disorders, epilepsy, globaldelays, or ADHD, comprising administering to a patient in need thereof anutrient composition that ameliorates one or more symptoms of apraxia,autism, speech impairments, traumatic brain injury, seizure disorders,epilepsy, global delays, or ADHD, said composition comprising aneffective amount of a mixture or purified mixture thereof comprisingthree or more botanical extracts selected from the group of botanicalsconsisting of Gymnema sylvestre, Commiphora mukul, Curcuma longa,Camellia sinensis, Emblica officinalis, and Terminalis chebula.

[Embodiment 2] A method according to Embodiment 1, for treating apraxiaor autism, or one or more symptoms thereof.

[Embodiment 3] A method according to Embodiment 1 or 2, for treatingapraxia or one or more symptoms thereof.

[Embodiment 4] A method according to Embodiment 1 or 2, for treatingautism, or one or more symptoms thereof.

[Embodiment 5] A method according to any one of Embodiments 1, 2, 3, and4, wherein the nutrient composition is in granular or powder form.

[Embodiment 6] A method according to any one of Embodiments 1, 2, 3, 4,and 5, wherein the nutrient composition is capable of being administeredorally.

[Embodiment 7] A method according to any one of Embodiments 1, 2, 3, 4,5 and 6, wherein the nutrient composition is combined with a liquidvehicle for oral consumption by the patient.

[Embodiment 8] A method according to Embodiment 7, wherein the liquidvehicle comprises water or milk.

[Embodiment 9] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, and 8, wherein the nutrient composition comprises a mixture orpurified mixture thereof comprising botanical extracts selected fromeach of Gymnema sylvestre, Commiphora mukul, Curcuma longa, Camelliasinensis, Emblica officinalis, and Terminalis chebula,

[Embodiment 10] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, and 9, wherein the nutrient composition further comprisesCinnamomum verum or Capsicum annuum.

[Embodiment 11] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, 9, and 10, wherein the nutrient composition furthercomprises an amino acid composition comprising one or more amino acids.

[Embodiment 12] A method according to Embodiment 11, wherein the aminoacid composition comprises a whey protein isolate.

[Embodiment 13] A method according to Embodiment 11 or 12, wherein theone or more amino acids contained in the amino acid composition areselected from the group consisting of: alanine, arginine, aspartic acid,cysteine, cystine, glutamic acid, glycine, histidine, isoleucine,leucine, lysine, methionine, phenylalanine, proline, serine, threonine,tryptophan, tyrosine, and valine.

[Embodiment 14] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, and 13, wherein the nutrient composition isgluten or casein free.

[Embodiment 15] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, and 14, wherein the nutrient compositionfurther comprises taurine or theanine.

[Embodiment 16] A method according to Embodiment15, wherein the taurineis L-taurine and the theanine is L-theanine.

[Embodiment 17] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, 9,10, 11, 12, 13, 14, 15, and 16, wherein the nutrientcomposition further comprises at least one copper containing compound.

[Embodiment 18] A method according to Embodiment 17, wherein the coppercompound containing nutrient composition further comprises at least onemetal containing compound, wherein the metal is selected from the groupconsisting of calcium, magnesium, zinc, selenium, manganese, chromium,and molybdenum.

[Embodiment 19] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, and 18, wherein thenutrient composition further comprises at least one vitamin.

[Embodiment 20] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, and 19, wherein theat least one vitamin is selected from the group consisting of vitamin A,vitamin B-1 (thiamine), vitamin B-2 (riboflavin), vitamin B-3 (niacin),vitamin B-5 (pantothenic acid), vitamin B-6, vitamin B-7 (biotin),vitamin B-9 (folic acid), vitamin B-12, vitamin C, vitamin D-3, andvitamin E.

[Embodiment 21] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, and 20, whereinthe nutrient composition further comprises at least one protein source.

[Embodiment 22] A method according to 21, wherein the at least oneprotein source comprises brown rice powder.

[Embodiment 23] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, and 22,wherein the nutrient composition further comprises at least one sourceof sugars, dietary fiber, or other carbohydrate.

[Embodiment 24] A method according to Embodiment 20, wherein the one ormore vitamins in an administered dose are present in the range of:

-   -   from about 2000 IU to about 3000 IU of vitamin A;    -   from about 1 mg to about 2 mg of vitamin B-1;    -   from about 1 mg to about 2 mg of vitamin B-2;    -   from about 10 mg to about 30 mg of vitamin B-3;    -   from about 5 mg to about 15 mg of vitamin B-5;    -   from about 1 mg to about 3 mg of vitamin B-6;    -   from about 10 mcg to about 50 mcg of vitamin B-7;    -   from about 200 mcg to about 600 mcg of vitamin B-9;    -   from about 2 mcg to about 10 mcg of vitamin B-12;    -   from about 30 mg to about 90 mg of vitamin C;    -   from about 200 IU to about 600 IU of vitamin D-3; and    -   from about 10 IU to about 50 IU of vitamin E.

[Embodiment 25] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23,and 24, wherein the nutrient composition further comprises iodine.

[Embodiment 26] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23,24, and 25, wherein the nutrient composition further comprises

(a) whey protein isolate, L-taurine, L-theanine, vitamin A (as retinolpalmitate), vitamin B-1 (as thiamine mononitrate), vitamin B-2 (asriboflavin), vitamin B-3 (as niacinamide), vitamin B-5 (as d-capantothenate), vitamin B-6 (as pyridoxine HCl), vitamin B-7 (as biotin),vitamin B-9 (as folic acid), vitamin B-12 (as cyanocobalamin), vitamin C(as ascorbic acid), vitamin D-3 (as cholecalciferol), and vitamin E (asd-alpha tocopherol), brown rice powder, sugar, apple fiber, cocoapowder, xanthan gum, potassium gluconate, calcium lactate, stevia,iodine yeast, chromium yeast, manganese yeast, zinc gluconate, seleniumyeast, magnesium oxide, copper gluconate, and molybdenum yeast, and

(b) cocoa flavor and Capsicum annuum; or

vanilla flavor and Cinnamomum verum.

[Embodiment 27] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23,24, 25, and 26, further comprising an effective amount of an omega 3fatty acid or pharmaceutically acceptable or food grade acceptablederivative thereof.

[Embodiment 28] A method according to Embodiment 27, wherein the omega 3fatty acid or pharmaceutically acceptable or food grade acceptablederivative thereof is provided in granular or powder form.

[Embodiment 29] A method according to Embodiment 27 or 28, wherein theomega 3 fatty acid or pharmaceutically acceptable or food gradeacceptable derivative thereof wherein the omega 3 fatty acid orpharmaceutically acceptable or food grade acceptable derivative thereofis microencapsulated.

[Embodiment 30] A nutrient composition comprising:

an effective amount of a mixture or purified mixture thereof comprisingthree or more botanical extracts selected from the group of botanicalsconsisting of Gymnema sylvestre, Commiphora mukul, Curcuma longa,Camellia sinensis, Emblica officinalis, and Tterminalis chebula; and

an effective amount of an omega 3 fatty acid or pharmaceuticallyacceptable or food grade acceptable derivative thereof.

[Embodiment 31] A composition according to Embodiment 30, wherein theomega 3 fatty acid or pharmaceutically acceptable or food gradeacceptable derivative thereof is provided in powder form.

[Embodiment 32] A composition according to Embodiment 30 or 31, whereinthe omega 3 fatty acid or pharmaceutically acceptable or food gradeacceptable derivative thereof is provided in microencapsulated powderform.

[Embodiment 33] A composition according to any one of Embodiments 30,31, and 32, wherein the nutrient composition further comprises aneffective amount of an omega 6 fatty acid or pharmaceutically acceptableor food grade acceptable derivative thereof.

[Embodiment 34] A composition according to Embodiment 33, wherein theomega 6 fatty acid is selected from GLA and DGLA, or pharmaceuticallyacceptable or food grade acceptable derivative thereof.

[Embodiment 35] A method according to any one of Embodiments 1, 2, 3, 4,5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23,24, 25, 26, 27, 28, and 29, wherein the nutrient composition furthercomprises an effective amount of an omega 6 fatty acid orpharmaceutically acceptable or food grade acceptable derivative thereof.

[Embodiment 36] A method according to Embodiment 35, wherein the omega 6fatty acid is selected from GLA and DGLA, or pharmaceutically acceptableor food grade acceptable derivative thereof.

[Embodiment 37] A method enhancing cognitive function, comprisingadministering to a patient in need thereof a nutrient composition thatenhances one or more aspects of cognition; said composition comprisingan effective amount of a mixture or purified mixture thereof comprisingthree or more botanical extracts selected from the group of botanicalsconsisting of Gymnema sylvestre, Commiphora mukul, Curcuma longa,camellia sinensis, Emblica officinalis, and Terminalis chebula.

[Embodiment 38] A method according to Embodiment 37, wherein the aspectof cognition are selected from attention, learning, and memory.

[Embodiment 39] A method according to Embodiment 37 or 38, furthercomprising an effective amount of an omega 3 fatty acid orpharmaceutically acceptable or food grade acceptable derivative thereof.

[Embodiment 40] A method treating stroke or an associated symptomthereof, comprising administering to a patient in need thereof anutrient composition comprising an effective amount of a mixture orpurified mixture thereof comprising three or more botanical extractsselected from the group of botanicals consisting of Gymnema sylvestre,Commiphora mukul, Curcuma longa, Camellia sinensis, Emblica officinalis,and Terminalis chebula.

[Embodiment 41] A method according to Embodiment 40, further comprisingan effective amount of an omega 3 fatty acid or pharmaceuticallyacceptable or food grade acceptable derivative thereof.

[Embodiment 42] A method according to any one of Embodiments 37, 38, 39,40, and 41, wherein the nutrient composition is in granular or powderform.

[Embodiment 43] A method according to any one of Embodiments 37, 38, 39,40, 41, and 42, wherein the nutrient composition is capable of beingadministered orally.

[Embodiment 44] A method according to any one of Embodiments 37, 38, 39,40, 41, 42, and 43, wherein the nutrient composition is combined with aliquid vehicle for oral consumption by the patient.

[Embodiment 45] A method according to Embodiment 44, wherein the liquidvehicle comprises water or milk.

[Embodiment 46] A method according to any one of Embodiments 37, 38, 39,40, 41, 42, 43, 44, and 45, wherein the nutrient composition comprises amixture or purified mixture thereof comprising botanical extractsselected from each of Gymnema sylvestre, Commiphora mukul, Curcumalonga, Camellia sinensis, Emblica officinalis, and Terminalis chebula,

[Embodiment 47] A method according to any one of Embodiments 37, 38, 39,40, 41, 42, 43, 44, 45, and 46, wherein the nutrient composition furthercomprises Cinnamomum verum or Capsicum annuum.

[Embodiment 48] A method according to any one of Embodiments 37, 38, 39,40, 41, 42,43, 44, 45, 46, and 47, wherein the nutrient compositionfurther comprises an amino acid composition comprising one or more aminoacids.

[Embodiment 49] A method according to Embodiment 48, wherein the aminoacid composition comprises a whey protein isolate.

[Embodiment 50] A method according to Embodiment 48 or 49, wherein theone or more amino acids contained in the amino acid composition areselected from the group consisting of: alanine, arginine, aspartic acid,cysteine, cystine, glutamic acid, glycine, histidine, isoleucine,leucine, lysine, methionine, phenylalanine, proline, serine, threonine,tryptophan, tyrosine, and valine.

[Embodiment 51] A method according to any one of Embodiments 37, 38, 39,40, 41, 42,43, 44, 45, 46, 47, 48, 49, and 50, wherein the nutrientcomposition is gluten or casein free.

[Embodiment 52] A method according to any one of Embodiments 37, 38, 39,40, 41, 42,43, 44, 45, 46, 47, 48, 49, 50, and 51, wherein the nutrientcomposition further comprises taurine or theanine.

[Embodiment 53] A method according to 52, wherein the taurine isL-taurine and the theanine is L-theanine.

[Embodiment 54] A method according to any one of Embodiments 37, 38, 39,40, 41, 42,43, 44, 45, 46, 47, 48, 49, 50, 51, 52, and 53, wherein thenutrient composition further comprises at least one copper containingcompound.

[Embodiment 55] A method according to Embodiment 54, wherein the coppercompound containing nutrient composition further comprises at least onemetal containing compound, wherein the metal is selected from the groupconsisting of calcium, magnesium, zinc, selenium, manganese, chromium,and molybdenum.

[Embodiment 56] A method according to any one of Embodiments 37, 38, 39,40, 41, 42,43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, and 55,wherein the nutrient composition further comprises at least one vitamin.

[Embodiment 57] A method according to any one of Embodiments 37, 38, 39,40, 41, 42,43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, and 56,wherein the at least one vitamin is selected from the group consistingof vitamin A, vitamin B-1 (thiamine), vitamin B-2 (riboflavin), vitaminB-3 (niacin), vitamin B-5 (pantothenic acid), vitamin B-6, vitamin B-7(biotin), vitamin B-9 (folic acid), vitamin B-12, vitamin C, vitaminD-3, and vitamin E.

[Embodiment 58] A method according to any one of Embodiments 37, 38, 39,40, 41, 42,43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, and57, wherein the nutrient composition further comprises at least oneprotein source.

[Embodiment 59] A method according to 58, wherein the at least oneprotein source comprises brown rice powder.

[Embodiment 60] A method according to any one of Embodiments 37, 38, 39,40, 41, 42,43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57,58, and 59, wherein the nutrient composition further comprises at leastone source of sugars, dietary fiber, or other carbohydrate.

[Embodiment 61] A method according to Embodiment 57, wherein the one ormore vitamins in an administered dose are present in the range of:

-   -   from about 2000 IU to about 3000 IU of vitamin A;    -   from about 1 mg to about 2 mg of vitamin B-1;    -   from about 1 mg to about 2 mg of vitamin B-2;    -   from about 10 mg to about 30 mg of vitamin B-3;    -   from about 5 mg to about 15 mg of vitamin B-5;    -   from about 1 mg to about 3 mg of vitamin B-6;    -   from about 10 mcg to about 50 mcg of vitamin B-7;    -   from about 200 mcg to about 600 mcg of vitamin B-9;    -   from about 2 mcg to about 10 mcg of vitamin B-12;    -   from about 30 mg to about 90 mg of vitamin C;    -   from about 200 IU to about 600 IU of vitamin D-3; and    -   from about 10 IU to about 50 IU of vitamin E.

[Embodiment 62] A method according to any one of Embodiments 37, 38, 39,40, 41, 42,43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, and 61, wherein the nutrient composition further comprisesiodine.

[Embodiment 63] A method according to any one of Embodiments 37, 38, 39,40, 41, 42,43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 61, and 62, wherein the nutrient composition furthercomprises

(a) whey protein isolate, L-taurine, L-theanine, vitamin A (as retinolpalmitate), vitamin B-1 (as thiamine mononitrate), vitamin B-2 (asriboflavin), vitamin B-3 (as niacinamide), vitamin B-5 (as d-capantothenate), vitamin B-6 (as pyridoxine HCl), vitamin B-7 (as biotin),vitamin B-9 (as folic acid), vitamin B-12 (as cyanocobalamin), vitamin C(as ascorbic acid), vitamin D-3 (as cholecalciferol), and vitamin E (asd-alpha tocopherol), brown rice powder, sugar, apple fiber, cocoapowder, xanthan gum, potassium gluconate, calcium lactate, stevia,iodine yeast, chromium yeast, manganese yeast, zinc gluconate, seleniumyeast, magnesium oxide, copper gluconate, and molybdenum yeast, and

(b) cocoa flavor and Capsicum annuum; or

vanilla flavor and Cinnamomum verum.

[Embodiment 64] A method according to any one of Embodiments 37, 38, 39,40, 41, 42,43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 61, 62, and 63, further comprising an effective amount of anomega 3 fatty acid or pharmaceutically acceptable or food gradeacceptable derivative thereof.

[Embodiment 65] A method according to Embodiment 64, wherein the omega 3fatty acid or pharmaceutically acceptable or food grade acceptablederivative thereof is provided in granular or powder form.

[Embodiment 66] A method according to Embodiment 64 or 65, wherein theomega 3 fatty acid or pharmaceutically acceptable or food gradeacceptable derivative thereof wherein the omega 3 fatty acid orpharmaceutically acceptable or food grade acceptable derivative thereofis microencapsulated.

[Embodiment 67] A method according to any one of Embodiments 37, 38, 39,40, 41, 42,43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57,58, 59, 60, 61, 62, 63, 64, 65, and 66, wherein the nutrient compositionfurther comprises an effective amount of an omega 6 fatty acid orpharmaceutically acceptable or food grade acceptable derivative thereof.

[Embodiment 68] A method according to Embodiment 67, wherein the omega 6fatty acid is selected from GLA and DGLA, or pharmaceutically acceptableor food grade acceptable derivative thereof.

When ranges are used herein for physical properties, such as molecularweight, or chemical properties, such as chemical formulae, allcombinations and subcombinations of ranges and specific embodimentstherein are intended to be included.

The disclosures of each patent, patent application and publication citedor described in this document are hereby incorporated herein byreference, in their entirety.

The invention illustratively disclosed herein suitably may be practicedin the absence of any element which is not specifically disclosedherein. The invention illustratively disclosed herein suitably may alsobe practiced in the absence of any element which is not specificallydisclosed herein and that does not materially affect the basic and novelcharacteristics of the claimed invention.

Those skilled in the art will appreciate that numerous changes andmodifications can be made to the preferred embodiments of the inventionand that such changes and modifications can be made without departingfrom the spirit of the invention. It is, therefore, intended that theappended claims cover all such equivalent variations as fall within thetrue spirit and scope of the invention.

What is claimed:
 1. A method for enhancing one or more conditions ordisorders of cognitive function in a mammal in need thereof comprisingadministering to the mammal in need thereof therapeutically effectiveamounts of five or more botanical extracts selected from the groupconsisting of Gymnema sylvestre, Commiphora mukul, Curcuma longa,Camellia sinensis, Emblica officinalis, and Terminalia chebula.
 2. Amethod according to claim 1, wherein the five or more therapeuticallyeffective amounts of Gymnema sylvestre, Commiphora mukul, Curcuma longa,Camellia sinensis, Emblica officinalis, and Terminalia chebula arecombined in a nutrient composition.
 3. A method according to claim 1,wherein the administering further comprises a therapeutically effectiveamount of an omega-3 fatty acid.
 4. A method according to claim 4,wherein the administering further comprises a therapeutically effectiveamount of an omega-3 fatty acid.
 5. A method according to claim 1,wherein the mammal is suffering from cognitive dysfunction.
 6. A methodaccording to claim 2, wherein the mammal is suffering from cognitivedysfunction.
 7. A method according to claim 5, wherein the cognitivedysfunction is associated with a condition or disorder selected from thegroup consisting of: Alzheimer's Disease, mild cognitive impairment,age-related cognitive decline, vascular dementia, Parkinson's Diseasedementia, amyotrophic lateral sclerosis, Huntington's Disease, stroke,traumatic brain injury, AIDS-associated dementia, schizophrenia,Lewy-body variant of Alzheimer's Disease with or without associationwith Parkinson's Disease, Creutzfeld-Jakob Disease, Korsakoff sDisorder, learning disabilities caused by degenerative disorders,learning disabilities caused by non-degenerative disorders, cerebralsenility, vascular dementia, electric shock induced amnesia, memoryimpairment associated with depression or anxiety, memory impairmentassociated with surgical procedures including coronary artery bypassgrafting, Down's syndrome, and combinations thereof.
 8. A methodaccording to claim 6, wherein the cognitive dysfunction is associatedwith a condition or disorder selected from the group consisting of:Alzheimer's Disease, mild cognitive impairment, age-related cognitivedecline, vascular dementia, Parkinson's Disease dementia, amyotrophiclateral sclerosis, Huntington's Disease, stroke, traumatic brain injury,AIDS-associated dementia, schizophrenia, Lewy-body variant ofAlzheimer's Disease with or without association with Parkinson'sDisease, Creutzfeld-Jakob Disease, Korsakoff s Disorder, learningdisabilities caused by degenerative disorders, learning disabilitiescaused by non-degenerative disorders, cerebral senility, vasculardementia, electric shock induced amnesia, memory impairment associatedwith depression or anxiety, memory impairment associated with surgicalprocedures including coronary artery bypass grafting, Down's syndrome,and combinations thereof.
 9. A method according to claim 5, wherein thecognitive dysfunction is memory loss.
 10. A method according to claim 1,wherein the administration improves a condition or disorder of cognitionselected from attention, learning and memory.
 11. A method according toclaim 2, wherein the nutrient composition is in granular form or powderform.
 12. A method according to claim 2, wherein the nutrientcomposition is administered orally.
 13. A method according to claim 2,wherein the nutrient composition is administered with an edible foodcarrier or incorporated directly into a food.
 14. A method according toclaim 2, wherein the nutrient composition is combined with a liquidvehicle for oral consumption by the mammal.
 15. A method according toclaim 2, wherein the nutrient composition further comprises an aminoacid composition comprising one or more amino acids.
 16. A methodaccording to claim 15, wherein the amino acid composition comprises awhey protein isolate.
 17. A method according to claim 15, wherein theone or more amino acids contained in the amino acid composition areselected from the group consisting of: alanine, arginine, aspartic acid,cysteine, cystine, glutamic acid, glycine, histidine, isoleucine,leucine, lysine, methionine, phenylalanine, praline, serine, threonine,tryptphan, tyrosine, and valine.
 18. A method according to claim 2,wherein the nutrient composition further comprises L-taurine andL-theonine.
 19. A method according to claim 2, wherein the nutrientcomposition further comprises at least one copper containing compound.20. A method according to claim 19, wherein the copper compound furthercomprises at least one metal containing compound, wherein the metal isselected from the group consisting of calcium, magnesium, zinc,selenium, manganese, chromium, and molybdenum.
 21. A method according toclaim 2, wherein the nutrient composition further comprises at least onevitamin.
 22. A method according to claim 2, wherein the at least onevitamin is selected from the group consisting of vitamin A, vitamin B-1,vitamin B-2, vitamin B-3, vitamin B-5, vitamin B-6, vitamin B-7, vitaminB-9, vitamin B-12, vitamin C, vitamin D-3, and vitamin E.
 23. A methodaccording to claim 2, wherein the nutrient composition further comprisesat least one protein source.
 24. A method according to claim 1, whereinthe mammal is a human.